MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ANATOMIC SHELL SIZE 64 RIGHT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	504-02-64E-R
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Additional 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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
On unknown date, the patient experience infection after tha procedure.On an unknown date, revision surgery due to infection was performed.

• Brand Name: RESTORATION ANATOMIC SHELL SIZE 64 RIGHT
• 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: 10086302
• Report Number: 0002249697-2020-00970
• Device Sequence Number: 14069693
• Product Code: LPH
• UDI-Device Identifier: 07613327012460
• UDI-Public: 07613327012460
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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
• Report Date (Section B): 05/26/2020

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: 01/31/2022
• Device Model Number: 504-02-64E-R
• Device Catalogue Number: 504-02-64E-R
• Device Lot Number: HR6M1R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 05/26/2020
• 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: Hospitalization; Required Intervention