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 Separation (1562); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems Injury (2348); Joint Dislocation (2374); No Code Available (3191)

Event Date 12/22/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that surgeon revised patient's right hip due to head dis-associating from the trunnion.Revised to restoration modular system.

Manufacturer Narrative

An event regarding disassociation involving a metal femoral head was reported.An event for disassociation was confirmed through medical review.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar)." scratches were observed on the articulating and distal surface of the head.The taper of the head is shown in figures 9 and 10.Damage was also observed in the taper of the head.These damages are consistent with a loss of taper lock." the mar concluded: "damage was observed on the accolade trunnion, v40 head taper, and x3 insert.This damage was consistent with the head taper and accolade stem trunnion losing their taper lock.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: a medical review was performed and concluded: " in conclusion, there is substantial proof that an overload condition due to procedure related factors was present in the arthroplasty and contributing to a potential overload condition in the arthroplasty triggering the further adverse events with trunnion damage, metal substance loss and femoral head disassociation although it is not certain this was the only factor.More clinical or radiological information would be required to solve this case with more certainty although there is no evidence for device-related factors playing a role as also supported by the mar findings." device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: a material analysis concluded that "no material or manufacturing defects were observed on the surfaces examined." further to this a medical review was performed and concluded that "more clinical or radiological information would be required to solve this case with more certainty although there is no evidence for device-related factors playing a role as also supported by the mar findings." the exact cause of the event could not be determined.Additional information, including patient history and additional lateral x-rays are needed to fully investigate the event.If further relevant information becomes available, this investigation will be re-opened.

Event Description

It was reported that surgeon revised patient's right hip due to head dis-associating from the trunnion.Revised to restoration modular system.

• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5378354
• MDR Text Key: 36344765
• Report Number: 0002249697-2016-00142
• Device Sequence Number: 1
• Product Code: JDI
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2015

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: 06/30/2014
• Device Catalogue Number: 6260-9-236
• Device Lot Number: MEPATR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2015
• Initial Date FDA Received: 01/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 77