MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6260-9-240

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

Patient Problems Injury (2348); Joint Dislocation (2374); No Information (3190)

Event Date 07/19/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient dislocated hip.Surgeon removed head and liner.Surgeon states trunnionosis occurred.Surgeon put a new femoral head and acetabular liner in place.

Manufacturer Narrative

An event regarding dislocation involving an metal head was reported.The event was confirmed.Method & results: device evaluation and results: material analysis was performed that concludes "burnishing, scratches and third-body indentation were observed on the insert, which are common damage modes on uhmwpe.Debris was observed on the taper of the head.Eds showed the debris was consistent with a corrosion product and material transfer from the hip stem.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: as per material analysis it is concluded that "burnishing, scratches and third-body indentation were observed on the insert, which are common damage modes on uhmwpe.Debris were observed on the taper of the head.No material or manufacturing defects were observed on the surfaces examined." if the additional information will be received, this investigation will be reopened and re-evaluated.

Event Description

Patient dislocated hip.Surgeon removed head and liner.Surgeon states trunnionosis occurred.Surgeon put a new femoral head and acetabular liner in place.

• Brand Name: V40 COCR LFIT HEAD 40MM/+4
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 5879989
• MDR Text Key: 52241900
• Report Number: 0002249697-2016-02631
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Risk Manager
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Catalogue Number: 6260-9-240
• Device Lot Number: K92MKE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 224967-08/29/2016-007R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention