MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ANATOMIC SHELL SIZE 66 LEFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	504-02-66F-L
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was implanted, the packaging was returned for evaluation.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
As reported: "upon opening the implant listed above it was observed that the implant was loose in the inner packaging and had rubbed against the inner plastic walls creating plastic debris that was adhered to the porous surface of the implant.The implant was lavaged thoroughly and implanted".
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: 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.Please see nc for further information.
Event or Problem Description
As reported: "upon opening the implant listed above it was observed that the implant was loose in the inner packaging and had rubbed against the inner plastic walls creating plastic debris that was adhered to the porous surface of the implant.The implant was lavaged thoroughly and implanted.".

• Brand Name: RESTORATION ANATOMIC SHELL SIZE 66 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: 8214795
• Report Number: 0002249697-2019-00027
• Device Sequence Number: 16650578
• Product Code: LPH
• UDI-Device Identifier: 07613327012491
• UDI-Public: 07613327012491
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K151264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2021
• Device Catalogue Number: 504-02-66F-L
• Device Lot Number: PP6X0D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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: 56 YR
• Patient Weight: 81