MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-40H
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: delta un.Fem hd 40mm r40 16/18, cat# 6519-1-040, lot# 48947702; uni adaptor sleeve v40 ti, cat# 6519-t-100, lot# 48733503; mod con dist stem 24 x 155 mm, cat# 6276-7-024, lot# caxr610c; 21mm mod rev hip body/bolt stdcomponent level 9006-1-021, cat# 6276-1-021, lot# 42983603; tritanium revision acetabular, cat# 509-02-68h, lot# mmdnnk; gap plate screws, cat# 2080-0035, lot# mlrwrv; gap plate screws, cat# 2080-0020, lot# ph0k06; gap plate screws, cat# 2080-0035, lot# mlp2v8; gap plate screws, cat# 2080-0015, lot# 282a7n; gap plate screws, cat# 2080-0030, lot# rm7m9h.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 reported discrepancies.There have been no other events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
It was reported that patient's right hip was revised due to possible infection (reported by surgeon, unknown if confirmed by pathology, not identified).Surgeon revised a ceramic head and sleeve, and poly liner to smaller components of the same type.

• Brand Name: TRIDENT 0 DEG INSERT 40MM
• 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: 7625015
• Report Number: 0002249697-2018-01904
• Device Sequence Number: 205124
• Product Code: LPH
• UDI-Device Identifier: 07613327025330
• UDI-Public: 07613327025330
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

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: 04/30/2019
• Device Catalogue Number: 623-00-40H
• Device Lot Number: MNHRVP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/21/2018
• 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: 67 YR
• Patient Weight: 100