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	01/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: 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, 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.The following devices were also listed in this report: bowed conical stem 19 x 195mm restoration modular hip system; cat#6276-7-219; lot# caxr419f; 23mm mod rev hip body/bolt stdcomponent level 9006-1-023; cat#6276-1-023; lot#64894604; delta v-40 ceramic head 36/+5; cat#6570-0-236; lot#65217701; tritanium revision acetabular; cat#509-02-58f; lot#lt0x43; gap plate screws; cat#2080-0030; lot#nx59rh; gap plate screws; cat#2080-0030; lot#ap22re; gap plate screws; cat#2080-0025; lot#453eh9.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
Dr reports patient was a status post conversion from an im nail to a restoration modular hip stem/total hip on (b)(6) 2018.He is now infected and dr would like to perform a one stage washout with exchange of stem.Implants were removed using extraction tools.The liner was removed as well.He decided to leave the cup in place.Dr proceeded to wash out the wound.He then reimplanted a restoration modular stem, head and new liner.The procedure was performed without incident.No further information is available due to emr password secured medical records.Update 11/january/2019: rep reported after first request for additional information that the im nail was a competitor device, no stryker devices were revised.

• 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: 8304654
• Report Number: 0002249697-2019-00472
• Device Sequence Number: 13857926
• Product Code: LPH
• UDI-Device Identifier: 07613327039924
• UDI-Public: 07613327039924
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

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: 12/31/2022
• Device Catalogue Number: 623-10-36F
• Device Lot Number: 953X2R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 02/05/2019
• 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: 83 YR
• Patient Weight: 73