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 Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

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.Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

Hip revision of accolade tmzf stem with disassociated head.

Event Description

Hip revision of accolade tmzf stem with disassociated head.

Manufacturer Narrative

An event regarding disassociation involving a v40 cocr lfit head that was mated with an accolade stem was reported.The event was confirmed through clinician review of the x-rays provided.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 29 march 2019 which indicated: damage was observed on the distal rim of the head, consistent with contact against the stem.Damage is also observed on the taper of the head.This damage was likely from the interaction between the head taper and the trunnion.A detailed image of the proximal end of the taper shows a step.The material analysis report revealed; damage was observed on the stem trunnion and head taper.This damage was consistent with wear mechanisms due to the cyclic contact between the head taper and stem trunnion after the loss of their taper lock.Debris was also observed on the stem trunnion.Eds showed the stem was consistent with astm f1813 alloy, the head was consistent with astm f1537 alloy and the debris was consistent with a corrosion product, stem base alloy and biological material.Clinician review: a review of the provided medical records by a clinical consultant indicated: x-ray printouts available for review include an x-ray dated october 19, 2008, which is an ap of the left hip demonstrating an uncemented left total hip arthroplasty with no screws in the acetabulum.The hip is reduced and the components are in nominal position.Skin staples are in situ.An x-ray dated january 20, 2019 is an ap of the pelvis demonstrating a left uncemented total hip arthroplasty.The stem and acetabular shell are essentially unchanged with the head remaining in the acetabulum with the trunnion disassociated and dislocated from the head with superior erosion of the trunnion noted on this x-ray.An x-ray dated january 23, 2019 is a lateral of the left hip demonstrating a reduced, uncemented total hip arthroplasty with a modular long stem and a cerclage cable distal to the lesser trochanter.Skin staples are in situ.No clinical or past medical history, no revision operative report, and no serial x-rays between the october 2008 primary surgery and january 2019 are available for review.Based upon the available information, no determination can be made regarding the cause of the loss of locking of the head/trunnion interface occurring after more than ten years in situ.Product history review: indicated all devices were manufactured and accepted into final stock on 05 may 2008 with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: 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 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.

• 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
• MDR Report Key: 8358354
• MDR Text Key: 136763327
• Report Number: 0002249697-2019-01125
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• Combination Product (y/n): N
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

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: 05/30/2013
• Device Catalogue Number: 6260-9-236
• Device Lot Number: 7V9MHE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 05/02/2019
• Supplement Dates FDA Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 90