MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-54F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Pain (1994); Injury (2348)
Date of Event	06/27/2016
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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
Took the accolade 1 stem out and went back with a rest mod and an mdm liner and head."on (b)(6) 2013 she was seen in an emergency room visit for pain in the right hip of twenty-four hours duration and it was noted, "fell on right side yesterday.X-ray right: periprosthetic acetabular fracture.Treat: non-weightbearing with a walker.On (b)(6) 2016 a revision right total hip arthroplasty, including the femoral stem, head and acetabular liner was performed for a post-operative diagnosis of "broken internal prosthesis right hip.X-ray of (b)(6) 2016 is an ap pelvis demonstrating disassociation of femoral trunnion from arthroplasty head which remains in the acetabulum.Trunnion deformity is noted.".

• Brand Name: TRIDENT PSL HA CLUSTER 54MM
• 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: 7654990
• Report Number: 0002249697-2018-02008
• Device Sequence Number: 163559
• Product Code: LPH
• UDI-Device Identifier: 07613327037203
• UDI-Public: 07613327037203
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

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: 06/30/2012
• Device Catalogue Number: 542-11-54F
• Device Lot Number: 0XMMKD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 07/02/2018
• 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: 62 YR
• Patient Weight: 49