MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +8 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6260-5-332

Device Problems Degraded (1153); Fracture (1260); Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problem Foreign Body Reaction (1868)

Event Date 08/22/2022

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.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.Device not returned to the manufacturer.

Event Description

As reported by rep: "case report: patient who underwent surgery approximately 12 years ago for a left total hip arthroplasty, presented with pain and x-rays showed a femoral head disassociation from the trunnion of the stem.The original stryker implants implanted were: accolade tmzf size 3x132 stem, a 32+8 v40 cocr femoral head, a size 50 trident psl ha hemispherical acetabular shell, with no screws, and size 32 e 10° x3 polyethylene liner.The patient was brought into the operating room, a revision hip was performed on the left side, the head was fractured from the trunnion on the stem.Rep confirmed the head had worn the trunnion down and became dissociated, the stem did not fracture, the head was free in the acetabulum causing impingement and metallosis.There was adverse local tissue reactions from the trunnionosis however the adductors were intact.Another company's revision stem was used, the trident cup was retained and a new 36mm size e 10 0° liner was put into the cup.".

• Brand Name: 32MM +8 V40 TAPER VIT 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 NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15433456
• MDR Text Key: 300026390
• Report Number: 0002249697-2022-01352
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327012934
• UDI-Public: 07613327012934
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Model Number: 6260-5-332
• Device Catalogue Number: 6260-5-332
• Device Lot Number: 23392101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2007
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female