MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-336

Device Problems Mechanical Problem (1384); Material Separation (1562)

Patient Problems Failure of Implant (1924); Injury (2348); Ambulation Difficulties (2544)

Event Date 01/12/2015

Event Type  Injury  

Event Description

A trunnion failure was reported, the head disassociated.

Manufacturer Narrative

Catalog number is unknown at this time.The device was reported as an unknown head.Additional information has been requested and if received, will be provided in the supplemental report.Device not returned.

Manufacturer Narrative

An event regarding disassociation involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event was not confirmed.Method & results: device evaluation and results: the device was not returned for analysis.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary operative reports, clinical and past medical history, serial dated x-rays and examination of explanted components.Device history review: all 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 reported lot.Conclusions: the subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall 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

A trunnion failure was reported, the head disassociated.

• Brand Name: V40 COCR LFIT HEAD 36MM/+10
• 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: 4583212
• MDR Text Key: 5482929
• Report Number: 0002249697-2015-00631
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

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: 03/31/2011
• Device Catalogue Number: 6260-9-336
• Device Lot Number: TP8MEA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2015
• Initial Date FDA Received: 03/09/2015
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR