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

Catalog Number 504-02-54C-L

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

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Upon incoming inspection, it was noticed that the implants were loose in packaging.The implants have been shipped to the (b)(4) lab.No further information available.

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 one other similar event for the reported lot.Conclusion: nc was raised on 21 june 2019 to evaluate the root cause, which indicates that due to misplacement of the implant from the post, the implant is free to move around in the blister.This causes the rough surface of the implant to abrade the petg blister walls causing debris.The hazard related to this packaging issue results in the implant disassociating from its post within the packaging prior to surgery, ultimately leading to the patient being exposed to excessive coating debris/unintended foreign object (petg and tpu packaging particulates).

Event Description

Upon incoming inspection it was noticed that the implants were loose in packaging.The implants have been shipped to the decon lab.No further information available.

• Brand Name: RESTORATION ANATOMIC SHELL SIZE 54 LEFT
• 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: 8739105
• MDR Text Key: 149394770
• Report Number: 0002249697-2019-02414
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327012354
• UDI-Public: 07613327012354
• 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: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 504-02-54C-L
• Device Lot Number: PN1X3T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other