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

Model Number 6260-9-244

Device Problems Degraded (1153); Material Erosion (1214); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body Reaction (1868); Ambulation Difficulties (2544)

Event Date 10/25/2022

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 that the patient's left hip was revised due to trunnion wear and head dissociation.Intra-operatively, it was discovered the trunnion dug through the liner and was articulating against the shell, causing additional wear.Metallosis was also noted.The stem, head, and liner were revised.Rep can provide pictures, and confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding disassociation and wear involving a metal head was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection of the returned devices indicated that damage consistent with the loss of taper lock was observed on the head and stem.Damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of capa.No further material analyses were performed.Clinician review: a review of the provided medical records by a clinical consultant indicated: conclusion of assessment: trunnion wear leading to disarticulation of head from stem.Device or procedure related adverse event: disarticulation of head from stem with catastrophic trunnion wear.Root cause and confirmation: the root cause of the failure leading to need for revision was the trunnion wear and disarticulation of the head.The root cause of the trunnion wear cannot be defined without additional information.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.Conclusion: the subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of nc and 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 analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.

Event Description

It was reported that the patient's left hip was revised due to trunnion wear and head dissociation.Intra-operatively, it was discovered the trunnion dug through the liner and was articulating against the shell, causing additional wear.Metallosis was also noted.The stem, head, and liner were revised.Rep can provide pictures, and confirmed that no further information will be released by the hospital or surgeon.

• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15803532
• MDR Text Key: 303703063
• Report Number: 0002249697-2022-01639
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032758
• UDI-Public: 07613327032758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061434
• 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: 02/03/2023

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: 11/30/2012
• Device Model Number: 6260-9-244
• Device Catalogue Number: 6260-9-244
• Device Lot Number: P0PMPD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male