MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 542-11-54F

Device Problems Defective Component (2292); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/05/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A 54mm psl shell had extra coating on it, and did not insert true to size.The defect was visible on the implant.A new 54mm psl shell was opened and had noticeably less coating, it was implanted true to size.

Manufacturer Narrative

An event regarding ha coating involving a trident shell was reported.This event was not confirmed.Method & results: -device evaluation and results: the returned device appears unremarkable.A visual inspection with acetabular coatings engineer indicated there is a little bit of discoloration in the hca coating but that is normal for this type of process.A dimensional inspection was performed.All features conformed to the required specifications with no evidence of a dimensional issue.-medical records received and evaluation: not performed as there is no evidence to support the event was related to patient factors.-device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies -complaint history review: there has been one other similar event for the lot referenced.Conclusions: a visual inspection with acetabular coatings engineer indicated there is a little bit of discoloration in the hca coating but that is normal for this type of process.A dimensional inspection was performed.All features conformed to the required specifications with no evidence of a dimensional issue.

Event Description

A 54mm psl shell had extra coating on it, and did not insert true to size.The defect was visible on the implant.A new 54mm psl shell was opened and had noticeably less coating, it was implanted true to size.

• Brand Name: TRIDENT PSL HA CLUSTER 54MM
• 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: 5919737
• MDR Text Key: 54294296
• Report Number: 0002249697-2016-02823
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• 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: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 542-11-54F
• Device Lot Number: JN61AM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2016
• 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