MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM REVISION ACETABULAR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	509-02-64G
Medical Device Problem Codes	Degraded (1153); Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: restoration adm x3 ins 28/54; cat# 1236-2-854; lot# 326662.Modular dual mobility insert; cat# 626-00-48g; lot# 76323704.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : device not returned.
Event or Problem Description
Total hip revision.Acetabular cup, mdm liner and mdm insert.
Additional Manufacturer Narrative
Reported event: an event regarding loosening and wear/metallosis involving a trident shell was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -product evaluation and results: the reported device was not returned; however, photographs were provided for review.The photographs show a recently explanted shell which is covered in biological material.Black tissue consistent with "metallosis" is present on the distal surface of the shell.Damage in the form of scratches can be seen on proximal surface of the shell, consistent with contact with explantation tooling.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient underwent primary total hip arthroplasty, a revision total hip arthroplasty for polyethylene liner disassociation, with metallosis, and then another revision for acetabular loosening with metallosis.The root cause of these events cannot be determined with certainty.The causes of both acetabular loosening, polyethylene, disassociation and metallosis, are multi factorial, including surgical technique, especially in the way preparation is made for insertion of the femoral head on the trunnion and the mdm liner into the acetabulum, as well as proper insertion of the polyethylene liner into a primary acetabular cup.Also contributing can be patient factors such as activity level and bmi, as well as implant factors." -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 lot referenced.Conclusions: it was reported that the patient was revised due to loosening of the acetabular component and metallosis.The reported device was not returned; however, photographs were provided for review.The photographs show a recently explanted shell which is covered in biological material.Black tissue consistent with "metallosis" is present on the distal surface of the shell.Damage in the form of scratches can be seen on proximal surface of the shell, consistent with contact with explantation tooling.It was not reported what devices caused or contributed to the reported metallosis, and the stem and head in this case were competitor devices.It is possible that the metallosis generated due to motion of the loose shell against the acetabular screws or between the metal mdm liner and the shell.The event was further confirmed via clinician review of the provided medical records: "the root cause of these events cannot be determined with certainty.The causes of both acetabular loosening, polyethylene, disassociation, and metallosis, are multi factorial, including surgical technique, especially in the way preparation is made for insertion of the femoral head on the trunnion and the mdm liner into the acetabulum, as well as proper insertion of the polyethylene liner into a primary acetabular cup.Also contributing can be patient factors such as activity level and bmi, as well as implant factors." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Total hip revision.Acetabular cup, mdm liner and mdm insert.Update per medical records received: the patient was revised due to loosening of the acetabular component and metallosis.

• Brand Name: TRITANIUM REVISION ACETABULAR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18444654
• Report Number: 0002249697-2024-00019
• Device Sequence Number: 15143853
• Product Code: LPH
• UDI-Device Identifier: 07613327025194
• UDI-Public: 07613327025194
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: 07/30/2021
• Device Catalogue Number: 509-02-64G
• Device Lot Number: 7K41K2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2016
• 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: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Race: White