MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ANATOMIC SHELL SIZE 54 RIGHT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 504-02-54C-R

Device Problems Packaging Problem (3007); Component Misassembled (4004)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.

Event Description

Upon incoming inspection it was noticed that the implant was loose in packaging.

Event Description

Upon incoming inspection it was noticed that the implant was loose in packaging.

Manufacturer Narrative

An event regarding a packaging issue involving a restoration shell was reported.The event was confirmed following visual inspection of the returned part.Method & results: device evaluation and results: visual inspection was performed and it was identified that there was damage caused to the blister walls and the implant.Material analysis, functional and dimensional inspections were not completed as these aspects are not in question.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices 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 packaging issue was confirmed following visual inspection of the returned part where it was identified that there was damage caused to the blister walls and the implant.Nc was initiated to evaluate the root cause of the event.

• Brand Name: RESTORATION ANATOMIC SHELL SIZE 54 RIGHT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8752358
• MDR Text Key: 149802773
• Report Number: 0002249697-2019-02459
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327012415
• UDI-Public: 07613327012415
• Combination Product (y/n): N
• PMA/PMN Number: K151264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 504-02-54C-R
• Device Catalogue Number: 504-02-54C-R
• Device Lot Number: HM5WKX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other