MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM REVISION ACETABULAR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	509-02-62G
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/04/2020
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
It was reported that the patient's hip was revised due to a loose shell.The titanium revision shell, alumina liner, and alumina head were revised.Rep confirmed there are no allegations against the revised liner and head.Regarding a revision shell being in situ, rep reported given the facts that the implantation took place at an unknown date in an unknown facility, the patient's age, and the patient's existing bone quality issues, the implantation was likely a primary surgery using a revision shell for its larger size to address the patient's bone quality issues.Rep provided explant pictures and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRITANIUM REVISION ACETABULAR
• 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: 10189384
• Report Number: 0002249697-2020-01282
• Device Sequence Number: 886788
• Product Code: LPH
• UDI-Device Identifier: 07613327025187
• UDI-Public: 07613327025187
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2020

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: 04/30/2018
• Device Model Number: 509-02-62G
• Device Catalogue Number: 509-02-62G
• Device Lot Number: MME1M7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/24/2020
• 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
• Patient Age: 39 YR
• Patient Weight: 95