MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +8 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6260-9-332

Device Problems Product Quality Problem (1506); Dull, Blunt (2407); Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the surgeon noticed a tarnishing or metallic hue that looked different than normal.It was reported that the surgeon did not implant the femoral head, and a second separate femoral head of the same size was used instead.

Manufacturer Narrative

An event regarding appearance involving a metal head was reported.The event was confirmed following visual inspection.Method & results: -device evaluation and results: visual inspection: the returned metal head showed signs of discoloration on the articulating surface.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review: all devices in the reported lot 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.Conclusion: the event was confirmed to be in the scope of an existing capa.The capa concluded the packaging foam is the source of the discoloration.

Event Description

It was reported that the surgeon noticed a tarnishing or metallic hue that looked different than normal.It was reported that the surgeon did not implant the femoral head, and a second separate femoral head of the same size was used instead.

• Brand Name: 32MM +8 LFIT V40 HEAD
• 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-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5678250
• MDR Text Key: 45881694
• Report Number: 0002249697-2016-01725
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121308
• 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: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 6260-9-332
• Device Lot Number: 38870806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2012
• 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