MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM 0 OFFSET; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-136
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994)
Date of Event	10/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.
Event or Problem Description
As reported by customers solicitor: on or around (b)(6) 2008 the claimant underwent a left hip replacement with a follow up operation on or around the (b)(6) 2009.It is submitted that the implants supplied were defective and due to the same the claimant's hip became infected subjecting the claimant to worsening hip pain from (b)(6) 2023 onwards.Following investigations it was discovered that corrosion of the implants was the cause of the ongoing infection/symptoms necessitating the removal and replacement of the defective implants.This revision surgery took place in (b)(6) 2023.
Event or Problem Description
As reported by customers solicitor: on or around (b)(6) 2008 the claimant underwent a left hip replacement with a follow up operation on or around the (b)(6) 2009.It is submitted that the implants supplied were defective and due to the same the claimant's hip became infected subjecting the claimant to worsening hip pain from (b)(6) 2023 onwards.Following investigations it was discovered that corrosion of the implants was the cause of the ongoing infection/symptoms necessitating the removal and replacement of the defective implants.This revision surgery took place in (b)(6) 2023.
Additional Manufacturer Narrative
An event regarding corrosion and infection involving an involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records evaluation: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: no medical records outlining the patient history were provided for review.No radiographs were provided for review.No laboratories or revision data were provided for review.The patient underwent a tha at the tail end of 2008.No data on the hospital stay and only a limited handwritten note provided on the procedure.The patient went back to the or on what appeared to be po day 4 for an exploration.The head and liner were exchanged.No other medical data were provided for review and the decision making for the return to or not provided.A revision in 2023 was reported by the patient¿s solicitor but no medical data provided.A claim of corrosion and defective implants was made.Event confirmation: a primary tha can be confirmed.A return to the or and head and liner exchange can be confirmed.A revision, corrosion of implants and defective implants cannot be confirmed.Root cause: the root cause of the primary tha was presumably oa but cannot be defined.The root cause of the return to the or cannot be ascertained.The root cause for the unconfirmed revision cannot be ascertained." device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: it was reported that the patient was revised due to infection and corrosion.A review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: no medical records outlining the patient history were provided for review.No radiographs were provided for review.No laboratories or revision data were provided for review.The patient underwent a tha at the tail end of 2008.No data on the hospital stay and only a limited handwritten note provided on the procedure.The patient went back to the or on what appeared to be po day 4 for an exploration.The head and liner were exchanged.No other medical data were provided for review and the decision making for the return to or not provided.A revision in 2023 was reported by the patient¿s solicitor but no medical data provided.A claim of corrosion and defective implants was made.Event confirmation: a primary tha can be confirmed.A return to the or and head and liner exchange can be confirmed.A revision, corrosion of implants and defective implants cannot be confirmed.Root cause: the root cause of the primary tha was presumably oa but cannot be defined.The root cause of the return to the or cannot be ascertained.The root cause for the unconfirmed revision cannot be ascertained." the subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall pfa was initiated for the lfit v40 cocr heads within scope of nc and capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before (b)(6) 2011.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.
Additional Manufacturer Narrative
Reported event: an event regarding corrosion and infection involving an involving a metal head was reported.The event was confirmed via medical review.Method & results: -device evaluation and results: not performed as product was not returned.-medical records evaluation: a review of the provided medical records by a clinical consultant indicated: event confirmation: "a primary tha can be confirmed.A return to the or and head and liner exchange can be confirmed.Revision surgery can be confirmed.Increased metal levels and some corrosion at the trunnion was documented.Infection was confirmed.A loose acetabular component was also noted.Recall cannot be confirmed.Root cause: the root cause of the primary tha was the root cause of the presumably oa but cannot be defined.The root cause of the wash out was concern for infection.The root cause of the revision surgery cannot be stated as it was proposed for ¿corrosion¿ some of which was found, but infection appeared to be the actual cause of the hip problem.Subsequent revisions were due to infection." -device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusions: it was reported that the patient was revised due to infection and corrosion.A review of the provided medical records by a clinical consultant indicated: event confirmation: "a primary tha can be confirmed.A return to the or and head and liner exchange can be confirmed.Revision surgery can be confirmed.Increased metal levels and some corrosion at the trunnion was documented.Infection was confirmed.A loose acetabular component was also noted.Recall cannot be confirmed.Root cause: the root cause of the primary tha was the root cause of the presumably oa but cannot be defined.The root cause of the wash out was concern for infection.The root cause of the revision surgery cannot be stated as it was proposed for ¿corrosion¿ some of which was found, but infection appeared to be the actual cause of the hip problem.Subsequent revisions were due to infection." a microbiological assessment was completed by a stryker microbiologist who indicated: "staphylococcus epidermidis have been identified as cause of infection of patient.Staphylococcus epidermidis, coagulase-negative staphylococci, have been considered innocuous commensals of human skin and mucous membranes but are now accepted as the leading opportunistic pathogens responsible for numerous nosocomial infections [1].In particular, they account for 30 to 43% of joint prosthesis infections [2].The current accepted pathophysiological mechanism of s.Epidermidis orthopedic device infection is the direct inoculation of skin colonizing strains at the time of surgery [2][3].Stryker can confirm that the origin of infection cannot have been the implants used for this tha surgery.Plastic (ultra-high molecular weight polyethylene) hip implants are gammairradiated between 25-35kgy for sterility assurance level (sal) of 10-6.Metal hip implants are gamma-irradiated between 25-45kgy for sal 10-6.X3 hip implants are subjected to overkill sterilisation cycles demonstrating sal 10-6 at half-cycle parameters.Conclusion: due to the nature of the organisms isolated ¿ susceptible to various modes of sterilisation - and the sterilisation methodology employed by stryker, it is not probable that staphylococcus epidermidis could have originated from the implants." the subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall pfa was initiated for the lfit v40 cocr heads within scope of nc and capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.
Event or Problem Description
As reported by customers solicitor: on or around (b)(6) 2008 the claimant underwent a left hip replacement with a follow up operation on or around the (b)(6) 2009.It is submitted that the implants supplied were defective and due to the same the claimant's hip became infected subjecting the claimant to worsening hip pain from (b)(6) 2023 onwards.Following investigations, it was discovered that corrosion of the implants was the cause of the ongoing infection/symptoms necessitating the removal and replacement of the defective implants.This revision surgery took place in (b)(6) 2023.(b)(6) 2025- update as per medical review: a loose acetabular component was also noted.

• Brand Name: V40 COCR LFIT HEAD 36MM 0 OFFSET
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20155371
• Report Number: 0002249697-2024-01214
• Device Sequence Number: 19886059
• Product Code: JDI
• UDI-Device Identifier: 07613327032307
• UDI-Public: 07613327032307
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K022077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: 6260-9-136
• Device Lot Number: KW0MMD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 10/10/2024; 01/21/2025
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/29/2024; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2249697-05-07-2018-003-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female