MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-10-36F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.The following devices were also listed in this report: v40 cocr lfit head 36mm/0; cat# 6260-9-136; lot# j740hd.Exeter 2.5 i m plug 12mm; cat# 09390112; lot# l8213.6.5 cancellous bone screw 25mm; cat# 2030-6525-1; lot# 1d8le7.6.5 cancellous bone screw 25mm; cat# 2030-6525-1; lot# a648p1.Exeter v40 stem 44mm no 1; cat# 0580-1-441; lot# g7327129.Trident hemispherical cluster hole shell; cat# 502-11-56f; lot# 64009502.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the reported 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
Patient has infection in right hip.Total hip replacement was (b)(6) 2018.Trident liner and femoral head replaced and hip washed out.Swabs and specimens sent.Patient had recent melanoma removed from back that had excess bleeding.
Additional Manufacturer Narrative
Lot code corrected.An event regarding infection involving a trident liner 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 or sterile lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Patient has infection in right hip.Total hip replacement was (b)(6) 2018.Trident liner and femoral head replaced and hip washed out.Swabs and specimens sent.Patient had recent melanoma removed from back that had excess bleeding.

• Brand Name: TRIDENT 10° 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: 8347689
• Report Number: 0002249697-2019-01074
• Device Sequence Number: 1923307
• Product Code: LPH
• UDI-Device Identifier: 07613327039924
• UDI-Public: 07613327039924
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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: 10/31/2022
• Device Catalogue Number: 623-10-36F
• Device Lot Number: 3J152W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 04/23/2019
• 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 Weight: 101