MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/-5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-036
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient is a 68 year old male who underwent surgery on (b)(6) 2010 for a left total hip arthroplasty, presented with pain and x-rays showed a femoral head dissociation from the trunnion of the stem as well as the trunnion fracturing off the neck of the body of the stem and floating free in the joint space.The original stryker implants implanted were: accolade tmzf size 4x132 stem, a 36-5 v40 cocr femoral head, a size 54 trident ha hemispherical acetabular shell, and two screws, and size 36 e neutral x3 polyethylene liner.No implant record available for the first surgery.The patient was brought into the operating room, a revision hip was performed on the left side, the trunnion was fractured from the stem, the head was free in the acetabulum causing impingement and metallosis.There was adverse local tissue reactions from the trunnionosis however the adductors were in tact.Another company's revision stem was used, the trident cup was retained and a new 36mm size e 10 degree liner was put into the cup.
Additional 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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported 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.

• Brand Name: V40 COCR LFIT HEAD 36MM/-5
• Common Device Name: 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15300045
• Report Number: 0002249697-2022-01242
• Device Sequence Number: 2467631
• Product Code: JDI
• UDI-Device Identifier: 07613327032291
• UDI-Public: 07613327032291
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K022077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2014
• Device Model Number: 6260-9-036
• Device Catalogue Number: 6260-9-036
• Device Lot Number: MHM0VW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male