MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM +4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6260-9-228

Device Problems Out-Of-Box Failure (2311); 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 03/03/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As per sales rep, he received product and information from sales rep.When the box was opened, it was noticed that there was some discoloration on the femoral.

Manufacturer Narrative

An event regarding appearance involving a metal femoral 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: no adverse consequences to the patient were reported and no information was provided, hence a medical review was not performed.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 has been no other similar events for the lot referenced.Conclusion: the event was confirmed.A technical assessment was performed for the reported failure mode and concluded: stryker¿s internal specification for ion implantation of cocr alloy bearings, ims0160, specifies in section 6.1.2 that processed components must be uniform in color and appearance over the treated area, and shall be free from discoloration.Based on the extensive testing carried out there is no indication to suggest a functional, biological or toxicological risk.Hence, no hazardous situations are foreseen as a result of implantation of a discolored femoral head.

Event Description

As per sales rep, he received product and information from sales rep.When the box was opened, it was noticed that there was some discoloration on the femoral.

• Brand Name: 28MM +4 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5514722
• MDR Text Key: 41048631
• Report Number: 0002249697-2016-00965
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 6260-9-228
• Device Lot Number: 51400804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2015
• 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