MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6260-9-236

Device Problems Material Erosion (1214); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530)

Event Date 01/24/2023

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.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 Description

Patient states that he is experiencing audible right hip "clacking", pain and right leg numbness since the summer of 2022 and is inquiring if products are subject to a recall.Patient obtained a second opinion to confirm "clacking" as primary surgeon denied hearing any noise and recommended physical therapy only.X-ray performed during second opinion showed the "ball is not angled correctly" and will require a "total reconstructive surgery", date tbd by primary surgeon on (b)(6) 2023 office visit.Patients states lab work shows elevated chromium and cobalt.Update 26 jan 23: patient states that his revision surgery is schedule for on (b)(6) 2023.Update 01 feb 23: patient stated his surgery has been moved up to on (b)(6) 2023, he was notified today of the surgery date change.Update 10 feb 23: email received from patient: "just had major surgery on my hip on tuesday.Complete revision.Femoral ball had worn angle stem to where it was about to brake.Black minerals throughout my thigh area & who knows where all.Some cleaned off, but much imbedded.This is no small issue.I will try to get pics of v40 femoral ball and rod as they were removed" "in therapy now and will need for weeks to come".Update: 13 feb 23: "the revision was due to trunnionosis metal taper on stem failed.I do not have many of the details but will try to get them".

Event Description

Patient states that he is experiencing audible right hip "clacking", pain and right leg numbness since the summer of 2022 and is inquiring if products are subject to a recall.Patient obtained a second opinion to confirm "clacking" as primary surgeon denied hearing any noise and recommended physical therapy only.X-ray performed during second opinion showed the "ball is not angled correctly" and will require a "total reconstructive surgery", date tbd by primary surgeon on (b)(6) 2023 office visit.Patients states lab work shows elevated chromium and cobalt.Update 26 jan 2023: patient states that his revision surgery is schedule for (b)(6) 2023.Update 01 feb 2023: patient stated his surgery has been moved up to (b)(6) 2023, he was notified today of the surgery date change.Update 10 feb 2023: email received from patient: "just had major surgery on my hip on tuesday.Complete revision.Femoral ball had worn angle stem to where it was about to brake.Black minerals throughout my thigh area & who knows where all.Some cleaned off, but much imbedded.This is no small issue.I will try to get pics of v40 femoral ball and rod as they were removed" "in therapy now and will need for weeks to come" update: 13 feb 2023: "the revision was due to trunnionosis¿metal taper on stem failed.I do not have many of the details but will try to get them".

Manufacturer Narrative

An event regarding adverse local tissue reaction(altr) and fretting involving a lfit v40 cocr head that was mated.The events were confirmed.Method & results: device evaluation and results: visual inspection of the provided photographs indicated a recently explanted device.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: this patient underwent a total hip arthroplasty in 2008 according to the product inquiry.Now the patient is experiencing pain with elevated cobalt and chromium levels requiring revision surgery.I actually have no definitive documentation of this patient's hip replacement since i have no office records, operation reports or x-rays.I can confirm that he has elevated cobalt and chromium levels which would be of concern for failure of the implant due to possible trunnionosis.In addition the patient was told that the femoral head was not angled correctly and that he would require revision surgery.Regarding the possibility of a recall stryker would have to check to see if this femoral head was indeed part of a recall.Regarding the root cause of this event, it is multifactorial and i cannot determine it with certainty.It can be contributed to by surgical technique, patient activity level and bmi and implant factors.Elevated cobalt and chromium levels with "clacking" and pain in the hip can be indicative of trunnionosis with femoral head/trunnion failure.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: review indicated there have been no other similar events for the reported lot.Conclusions: 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.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• Type of Device: 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16377289
• MDR Text Key: 309554818
• Report Number: 0002249697-2023-00155
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Model Number: 6260-9-236
• Device Catalogue Number: 6260-9-236
• Device Lot Number: 245MLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 03/16/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White