MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-00-36F
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: v40 cocr lfit head 36mm/+5;6260-9-236;1l8kt4.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that the surgeon performed an 'irrigation & debridement' of a total hip arthroplasty.When removing the polyethylene insert he noticed that the surface looked delaminated and scored.It was further reported that the index operation only occurred 4 weeks prior on (b)(6) 2020.
Event or Problem Description
It was reported that the surgeon performed an 'irrigation & debridement' of a total hip arthroplasty.When removing the polyethylene insert he noticed that the surface looked delaminated and scored.It was further reported that the index operation only occurred 4 weeks prior on (b)(6) 2020.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a trident liner was reported.The event was confirmed by material analysis.Method & results: product evaluation and results: visual inspection of the returned device noted the following: damage consistent with the explantation process was observed on the insert.A higher magnification image ofarticulating surface shows damage consistent with burnishing, scratching, and third body indentations.The damage modes present on the articulating surface are common damage modes.Material analysis of the returned device noted the following: conclusion: the damage present on the articulating surface of the insert was consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.Eds showed the head was consistent with astm f1537 and the debris on the interior taper was consistent with an oxide / corrosion process, biological material, material transfer from a object.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: it was reported that the surgeon performed an 'irrigation & debridement' of a total hip arthroplasty.When removing the polyethylene insert he noticed that the surface looked delaminated and scored.It was further reported that the index operation only occurred 4 weeks prior on (b)(6) 2020.3 ap hip xrays were reviewed: a preop fil showing advanced osteoarthritis and two post operative films showing a tha in expected position.Both postop xrays show the presence of a cerclage wire and a free bone fragment juxtaposed to the lesser trochanter.It is reasonable to assume that during the index surgery a calcar fracture occurred.No explanation for the need for an i & d or the delamination of the polyethylene can be gleaned from this information".Product history review: review of the device history records indicate 32 devices were manufactured and accepted into final stock on 13/01/2020 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: 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.

• Brand Name: TRIDENT 0 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: 10655501
• Report Number: 0002249697-2020-02095
• Device Sequence Number: 11454916
• Product Code: LPH
• UDI-Device Identifier: 07613327039535
• UDI-Public: 07613327039535
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 01/31/2025
• Device Model Number: 623-00-36F
• Device Catalogue Number: 623-00-36F
• Device Lot Number: 4Y54JV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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