MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 44MM/+0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-144

Device Problems Degraded (1153); Material Erosion (1214)

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

Event Date 09/21/2022

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) 2022 and was revised on (b)(6) 2022.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.

Manufacturer Narrative

Reported event: an event regarding wear and abnormal ion level involving a metal head was reported.The wear event was confirmed via evaluation of the provided photograph of the stem and clinician review of the provided medical records.Abnormal ion level was not confirmed.Method & results: product evaluation and results: the reported device was not returned however a photograph of the stem was provided for review.Visual inspection of the provided photograph indicated that the stem is severely worn consistent with loss of taper lock.Clinician review: a review of the provided medical records by a clinical consultant indicated: "this patient underwent a primary total hip arthroplasty in 2009 and then approximately 13 years later developed elevated metal ions, metallosis and trunnion failure requiring revision.I can confirm that the patient underwent the primary and revision procedure since i was able to review the operation reports.The root cause of this event cannot be determined with certainty.Causes of elevated ion levels, trunnion failure and metallosis are multifactorial including surgical technique, patient activity level and bmi, as well as implant factors." product 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 lot referenced.Conclusions: it was reported that the patient was revised due to elevated metal ion levels and severe wear of the stem trunnion at the stem-head junction.The subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of this 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

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) 2016 and was revised on (b)(6) 2022.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.Update per medical records, (b)(6) 2023: event is for the right hip, not left."gross metal debris encountered in the hip, with black metal staining of the periprosthetic tissues.The musculature around the hip was affected including portions of the abductors.Then the prior femoral head was removed with a bone tamp.The trunnion had grossly failed and deformed and was not salvagable.A synovectomy and debridement of the periprosthetic tissues and hip joint was performed.".

• Brand Name: V40 COCR LFIT HEAD 44MM/+0
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15986000
• MDR Text Key: 305493986
• Report Number: 0002249697-2022-01831
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032734
• UDI-Public: 07613327032734
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

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: 03/31/2014
• Device Catalogue Number: 6260-9-144
• Device Lot Number: MHD4YD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 10/04/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male