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

Model Number	623-00-40H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The following devices were also listed in this report: delta un.Fem hd 40mm r40 16/18; cat# 6519-1-040; lot# 38676701, uni adaptor sleeve c taper ti; cat# 19-0000t ; lot# 38515801, trident psl with purefix ha 62mm; cat# 542-11-62h; lot# 37653301, acetabular dome hole plug; cat# 2060-0000-1; lot# mkn626, secur-fit max 132 hip stem #10; cat# 6051-1035s; lot# mkphh2, d-m 2.0mm beaded cable set vit; cat# 6704-0-520; lot# 38578803, 6.5 cancellous bone screw 25mm; cat# 2030-6525-1; lot# mktv55, 6.5 cancellous bone screw 25mm; cat# 2030-6525-1; lot# mktklv.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : device not returned.
Event or Problem Description
While gathering information for a revision of the patient's right hip on (b)(6) 2022, rep was provided a usage sheet for a head/ liner exchange on (b)(6) 2022 due to infection.Rep confirmed that no stryker rep was present, and that no further information will be released by the hospital or surgeon.This report is for revision of the patient's right hip on (b)(6) 2022.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15514592
• Report Number: 0002249697-2022-01419
• Device Sequence Number: 5170865
• Product Code: LPH
• UDI-Device Identifier: 07613327025330
• UDI-Public: 07613327025330
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2022

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: 04/30/2016
• Device Model Number: 623-00-40H
• Device Catalogue Number: 623-00-40H
• Device Lot Number: MKHKE3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Male