MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Model Number	625-0T-28D
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Osteolysis (2377)
Date of Event	11/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Tha was performed on (b)(6) 2008 (j543-11-46d, 625-0t-28d).Revision was performed on (b)(6) 2021 due to metallosis.There was osteolysis around the acetabulum and proximal stem and it was treated with vancomycin and bone graft.The liner and head were replaced.The back of the liner showed metal wear debris.The doctor would like to know which part of the liner is worn and how much.Originally, is there any marking or unevenness on the tapered edge of the liner? surgeon said that there may have been something on it, but it disappeared due to wear.
Additional Manufacturer Narrative
Reported event: an event regarding wear (metallosis) and osteolysis involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device had scratches/nicks on the metal and ceramic surfaces.Damage is consistent with attempted implantation/explantation.No wear was observed on the device.No further surface discrepancies were observed.Material analysis: damage observed on the liner is consistent with attempted implantation/explantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 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.Conclusions: it was reported that the patient was revised due to reported wear (metallosis) and osteolysis.Visual inspection of the returned device indicated that no wear was observed on the surface of the device.The event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Tha was performed on (b)(6) 2008 (j543-11-46d, 625-0t-28d).Revision was performed on (b)(6) 2021 due to metallosis.There was osteolysis around the acetabulum and proximal stem and it was treated with vancomycin and bone graft.The liner and head were replaced.The back of the liner showed metal wear debris.The doctor would like to know which part of the liner is worn and how much.Originally, is there any marking or unevenness on the tapered edge of the liner? surgeon said that there may have been something on it, but it disappeared due to wear.

• Brand Name: TRIDENT ALUMINA INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12891214
• Report Number: 0002249697-2021-01982
• Device Sequence Number: 1492376
• Product Code: MRA
• UDI-Device Identifier: 04546540516831
• UDI-Public: 04546540516831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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: 10/31/2012
• Device Model Number: 625-0T-28D
• Device Catalogue Number: 625-0T-28D
• Device Lot Number: 24474402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2007
• 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; Required Intervention
• Patient Sex: Female
• Patient Weight: 50 KG