MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 44MM/-4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6260-9-044

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

Patient Problem Metal Related Pathology (4530)

Event Date 09/21/2022

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.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.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

It was reported that the patient's right hip was revised due to trunnion wear and metallosis.Intra-operatively, liner wear was also noted.The stem, head, and liner were revised.

Manufacturer Narrative

Reported event: an event regarding wear involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event of wear/ metallosis was confirmed.Method & results: product evaluation and results: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.The device fractured in overload at the point of wear.This has been documented as part of a capa.Clinician review: no medical records were provided for review with a clinical consultant.Product history review: review of the device history records indicate the 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's hip was revised due to trunnion wear and metallosis.The event was confirmed.Mar not performed as this has been documented as part of a capa.The subject device has been identified to be within scope of an 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 that the patient's right hip was revised due to trunnion wear and metallosis.Intra-operatively, liner wear was also noted.The stem, head, and liner were revised.Update following patient call, 11/29/2022: patient called and reported revision due to pain.Patient would like to know if components are subject to a recall.

• Brand Name: V40 COCR LFIT HEAD 44MM/-4
• 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: 15627992
• MDR Text Key: 301979513
• Report Number: 0002249697-2022-01512
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032710
• UDI-Public: 07613327032710
• 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: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

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: 06/30/2013
• Device Model Number: 6260-9-044
• Device Catalogue Number: 6260-9-044
• Device Lot Number: 3HMMKE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 108 KG