MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6260-9-232

Device Problems Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Discomfort (2330); Metal Related Pathology (4530)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2009 and was revised on (b)(6) 2021.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.

Manufacturer Narrative

Reported event: an event regarding corrosion, altr and abnormal ion level involving a metal head was reported.The events were confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a total hip replacement over 11 years after implantation due to trunnionosis and elevated ion levels.I can confirm that this event took place since i was able to review the revision operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of trunnionosis are multifactorial including surgical technique factors, patient factors, and implant factors.-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.  conclusion: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a total hip replacement over 11 years after implantation due to trunnionosis and elevated ion levels.I can confirm that this event took place since i was able to review the revision operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of trunnionosis are multifactorial including surgical technique factors, patient factors, and implant factors.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6), 2009 and was revised on (b)(6), 2021.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.Update based on medical review dated 26 march 2022.[.]"there was gray and tan colored synovium throughout the left hip consistent with a pseudotumor." [.] surgeon stated that the femoral head was challenging to remove.He found ¿substantial amount of corrosion over the trunnion as well as inside of the morse taper of the femoral head.This was consistent with trunnionosis.

• Brand Name: 32MM +4 LFIT V40 HEAD
• 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-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 13502313
• MDR Text Key: 285710520
• Report Number: 0002249697-2022-00205
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327013085
• UDI-Public: 07613327013085
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Model Number: 6260-9-232
• Device Catalogue Number: 6260-9-232
• Device Lot Number: 26256405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male