MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-50E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	06/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event:an event regarding altr involving a trident shell was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: 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 exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, histopathology reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available and/ or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that patient's right hip was revised due to adverse local tissue reaction.Rep reported that he provided all medical records available by hospital policy to him.Correction as per update received tuesday january 22nd 2019: the trident shell in situ from (b)(6) 2008 was revised (b)(6) 2018 (altr), not on (b)(6) 2018.At that time, an all-poly constrained liner was cemented into the patient¿s native acetabulum.

• Brand Name: TRIDENT PSL HA CLUSTER 50MM
• 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: 8292677
• Report Number: 0002249697-2019-00408
• Device Sequence Number: 2321279
• Product Code: LPH
• UDI-Device Identifier: 07613327037265
• UDI-Public: 07613327037265
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2019

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: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 542-11-50E
• Device Lot Number: LYNMEE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 01/31/2019
• 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
• Patient Age: 82 YR