MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM -4 LFIT V40 HEAD; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number 6260-9-032

Device Problems Material Discolored (1170); Device Damaged Prior to Use (2284); 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 08/05/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that when the customer open the box they feel that the head is discolored.

Manufacturer Narrative

An event regarding appearance involving a metal head was reported.The event was confirmed.Method & results: -device evaluation and results: discolouration was observed on the returned head.-medical records received and evaluation: insufficient 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 events for the reported lot.Conclusion: a review of the returned device was performed by a material scientist and inspection confirmed discoloration on the head.The femoral head demonstrated varying degrees of discoloration and discoloration observed is consistent with devices reported under nc.No further investigation is required as this event is within the scope of nc and capa.

Event Description

It was reported that when the customer open the box they feel that the head is discolored.

• Brand Name: 32MM -4 LFIT V40 HEAD
• Type of Device: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5050193
• MDR Text Key: 25399514
• Report Number: 0002249697-2015-02908
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 6260-9-032
• Device Lot Number: 49187403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2014
• 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