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

Catalog Number 6260-9-236

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

Patient Problems Joint Dislocation (2374); Ambulation Difficulties (2544)

Event Date 06/19/2023

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.H3 other text : device not returned.

Event Description

It was reported that the patient's right hip was revised due to dissociation of the femoral head from the stem caused by the wearing down of the trunnion.The stem, head, and liner were revised to a restoration modular stem construct, ceramic head, mdm/ adm poly insert and mdm metal liner.Rep confirmed there are no allegations against the femoral head, and that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding disassociation involving a metal head was reported.The event was confirmed through analysis of the device.Method & results product evaluation and results: visual inspection of the returned devices indicated that the trunnion of the stem is severely worn.The metal head appears to have damage from the disassociation event and explantation.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.Medical records received and evaluation: no medical records were received for review with a clinical consultant.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.Conclusions: it was reported that the patient was revised due to disassociation of the head from the stem, fracture of the stem trunnion.The subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall pfa 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 right hip was revised due to dissociation of the femoral head from the stem caused by the wearing down of the trunnion.The stem, head, and liner were revised to a restoration modular stem construct, ceramic head, mdm/ adm poly insert and mdm metal liner.Rep confirmed there are no allegations against the femoral head, and that no further information will be released by the hospital or surgeon.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17313848
• MDR Text Key: 318981381
• Report Number: 0002249697-2023-00769
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022077
• 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: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: 6260-9-236
• Device Lot Number: MJKDV5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2010
• 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): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female