MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-52E
Medical Device Problem Codes	Degraded (1153); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Inflammation (1932); Injury (2348); Reaction (2414); Inadequate Osseointegration (2646)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Based on the device identification the complaint databases were reviewed for similar reported events regarding loosening.Lot id: 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
Patient underwent a prosthetic bilateral hip surgical procedure for a coxarthrosis on (b)(6) 2012 with an abgii mod.On (b)(6) 2017, he underwent a revision surgery of the right stem due to the metallosis.On (b)(6) 2017, he underwent a revision of the left prosthesis due to the mobilization of the acetabular component and periprosthetic calcifications of the left hip.This pi is for revision of the left hip.

• Brand Name: TRIDENT PSL HA CLUSTER 52MM
• 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: 8291330
• Report Number: 0002249697-2019-00407
• Device Sequence Number: 2462738
• Product Code: LPH
• UDI-Device Identifier: 07613327037197
• UDI-Public: 07613327037197
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2019

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: No Information
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 542-11-52E
• Device Lot Number: 38012801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/30/2019
• 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: Hospitalization; Required Intervention