MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ANATOMIC SHELL SIZE 60 LEFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	504-02-60D-L
Medical Device Problem Codes	Material Deformation (2976); Packaging Problem (3007); Component Misassembled (4004)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, left tha.It was reported that when the size 60 shell was opened, the shell had come off the post that holds it in place in the packaging and some of the outer beading was abraded off the shell.A size 62 shell was opened, and was also loose in the packaging with some of the outer beading removed.The surgeon decided to go with a revision shell which was available in the operating room.Surgery was completed successfully with a delay of less than a minute.
Additional 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: nc was raised on (b)(6) 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 or Problem Description
Primary procedure, left tha.It was reported that when the size 60 shell was opened, the shell had come off the post that holds it in place in the packaging and some of the outer beading was abraded off the shell.A size 62 shell was opened, and was also loose in the packaging with some of the outer beading removed.The surgeon decided to go with a revision shell which was available in the operating room surgery was completed successfully with a delay of less than a minute.

• Brand Name: RESTORATION ANATOMIC SHELL SIZE 60 LEFT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8687104
• Report Number: 0002249697-2019-02213
• Device Sequence Number: 2349135
• Product Code: LPH
• UDI-Device Identifier: 07613327012422
• UDI-Public: 07613327012422
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K151264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 504-02-60D-L
• Device Lot Number: 633D81
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR