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 Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 09/27/2023

Event Type  Injury  

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.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.

Event Description

It was reported that the patient's right hip was revised due to significant trunnion damage and partial dissociation of the femoral head.The stem and head were revised.

Manufacturer Narrative

Reported event: an event regarding disassociation involving a metal head was reported.The event was confirmed via evaluation of the returned devices.Method & results: product evaluation and results: visual inspection: visual inspection of the returned devices indicated that damage consistent with the loss of taper lock was observed on the head and stem.Material analysis: 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: 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 wear of the stem and loss of taper lock.Visual inspection of the returned devices indicated that damage consistent with the loss of taper lock was observed on the head and stem.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 right hip was revised due to significant trunnion damage and partial dissociation of the femoral head.The stem and head were revised.

• 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: 17972114
• MDR Text Key: 326123844
• Report Number: 0002249697-2023-01221
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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: 11/30/2013
• Device Catalogue Number: 6260-9-236
• Device Lot Number: 9K1MPE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2008
• 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): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 80 KG