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 Corroded (1131); Degraded (1153); Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

An event regarding revision surgery involving a metal head was reported.Corrosion was confirmed.Method and results: -device evaluation and results: a material analysis was performed on the returned device which concluded: "discoloration was observed on the stem trunnion and head taper.Eds showed the discoloration was consistent with a corrosion process, material transfer from the stem, the decontamination process and biological material.-medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the root cause of the event could not be determined because insufficient medical information was provided.Further information such as operative reports, x-rays, clinical and past medical history are needed to investigate this event further.If additional information becomes available, this investigation will be reopened.

Event Description

The customer reported that the surgeon, mr (b)(6), undertook a revision case for an exeter stem, liner and metal head in a (b)(6) female on (b)(6) 2016.The devices were originally implanted in (b)(6) 2011.

• 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: 6562317
• MDR Text Key: 74985765
• Report Number: 0002249697-2017-01523
• 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: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2017

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: 11/16/2015
• Device Catalogue Number: 6260-9-236
• Device Lot Number: MJPD55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Initial Date Manufacturer Received: 04/13/2017
• Initial Date FDA Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2010
• 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): Other; Required Intervention
• Patient Age: 72 YR