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 Problem Material Erosion (1214)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 09/16/2020

Event Type  Injury  

Event Description

It was reported by the patient's attorney as a result of a legal claim that allegedly the patient was implanted with an lfit cocr v40 femoral head on his left hip on (b)(6) 2013.It is further alleged that he suffered progressive groin and left hip pain, elevated cobalt level at 4.3 and on (b)(6) 2020 underwent revision surgery of the acetabular liner and femoral head.

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.

• 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: 15122263
• MDR Text Key: 296781836
• Report Number: 0002249697-2022-01099
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2022

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: 11/30/2018
• Device Model Number: 6260-9-044
• Device Catalogue Number: 6260-9-044
• Device Lot Number: MMNPHE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2013
• 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 Age: 62 YR
• Patient Sex: Male