MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-36G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: delta c-taper head 36mm +0e; cat# 18-3600; lot# 67206702.Rest ha -5 red nk 205mm strt stm 9x15mm; cat# s-2652-0915; lot# d65568r.Gap plate screws; cat# 2080-0040; lot# mml2em.Gap plate screws; cat# 2080-0040; lot# 352e32.Gap plate screws; cat# 2080-0040; lot# 5j2e4m.Md vit slv and 2.0mm homog cbl; cat# 6704-0-510; lot# 67528309.Md vit slv and 2.0mm homog cbl; cat# 6704-0-510; lot# 67541607.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 the revision of the patient's left hip on (b)(6) 2019.Postoperative diagnosis: patient had total left hip arthroplasty several years ago (outside cors scope).Patient had persistent and progressive pain in the left hip for many years.X-rays confirmed loosening of the femoral component.Revision of both acetabular and femoral components (b)(6) 2018.Patient had chronic infection after revision arthroplasty, and underwent left hip arthroplasty with placement of antibiotic- loaded cement spacer (b)(6) 2018.This was reported in (b)(4).The patient presented drainage from left thigh incision and in (b)(6) 2019 had a resection arthroplasty with antibiotic-loaded cement spacer for his infected left hip.In (b)(6) 2019, patient underwent two- stage reimplantation.

• Brand Name: TRIDENT 0° X3 INSERT 36MM 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: 8821682
• Report Number: 0002249697-2019-02652
• Device Sequence Number: 16765294
• Product Code: LPH
• UDI-Device Identifier: 07613327039528
• UDI-Public: 07613327039528
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2019

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: 08/31/2023
• Device Catalogue Number: 623-00-36G
• Device Lot Number: ME0542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/24/2019
• 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: 60 YR
• Patient Weight: 95