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

Catalog Number	623-00-40F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial information was provided by legal.No additional information is available at this time due to the ongoing litigation.Additional devices listed in this report: catalog: 542-11-56f description: trident psl ha cluster 56mm lot: v3ymad, catalog: 2030-6535-1 description: 6.5 cancellous bone screw 35mm lot: 97009903, catalog: 2030-6530-1 description: 6.5 cancellous bone screw 30mm lot: mwymla.At this time, it cannot be determined which, if any of the reported devices may have caused or contributed to the patient's experience.Additional information has been requested and if received will be provided in a supplemental report.Not available.
Event or Problem Description
Subsequent to the revision surgery for the intraprosthetic dissociation, the patient underwent extensive rehabilitation of the revised hip and developed a post-operative infection resulting in a 2 stage infection surgery with placement of an antibiotic.
Event or Problem Description
Subsequent to the revision surgery for the intraprosthetic dissociation, the patient underwent extensive rehabilitation of the revised hip and developed a post-operative infection resulting in a 2 stage infection surgery with placement of an antibiotic.
Additional Manufacturer Narrative
An event regarding infection involving a trident liner was reported.The event was not confirmed.Device evaluation and results: not performed as product was not returned.No medical records were received for review with a clinical consultant.All devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot or sterile lot.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, pathology 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.

• 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: 7588202
• Report Number: 0002249697-2018-01764
• Device Sequence Number: 19319295
• Product Code: LPH
• UDI-Device Identifier: 07613327025316
• UDI-Public: 07613327025316
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

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: 01/31/2012
• Device Catalogue Number: 623-00-40F
• Device Lot Number: 8R1MAD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 08/10/2018
• 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; Other; Required Intervention