MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° CROSSFIRE INSERT 28 MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	621-10-28D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	03/09/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: primary tritanium hemi cluster hole cup 50mm; cat# 502-03-50d; lot# 48408401, 6.5 cancellous bone screw 20mm; cat# 2030-6520-1; lot# mnma5w, 6.5 cancellous bone screw 25mm; cat# 2030-6525-1; lot# mnmdrl, v40 fem head orthinox 28-4; cat# 6364-2-028; lot# g5044938, accolade plus tmzf hip stem #1; cat# 6021-0130; lot# 46575202.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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
This pi is for revision 1 done on (b)(6) 2015 patient had a right hip replacement done on (b)(6) 2014.Patient was revised 3 times due to infection and other complications.

• Brand Name: TRIDENT 10° CROSSFIRE INSERT 28 MM ID
• 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: 8526905
• Report Number: 0002249697-2019-01659
• Device Sequence Number: 13920907
• Product Code: LPH
• UDI-Device Identifier: 07613327037746
• UDI-Public: 07613327037746
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K983502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

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: 06/30/2019
• Device Catalogue Number: 621-10-28D
• Device Lot Number: MNKD95
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/18/2019
• 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: 56 YR