MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER54E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	702-04-54E
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Inflammation (1932); Osteolysis (2377)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding fretting involving an unknown shell was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review:no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: it was reported that patient had a revision due to corrosion noted on the back of the mdm liner, on the inner surface of the acetabular shell and in the joint fluid and pelvic osteolysis.The event could not be confirmed nor the exact cause be determined because insufficient information was provided.Additional information including device details, operative 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.Device not returned.
Event or Problem Description
It was reported the patient's left mako hip was revised due to corrosion, fluid buildup, metal debris, and massive pelvic osteolysis.An mdm metal liner, adm/ mdm poly insert, and femoral head of unknown composition were revised to a 40mm x3 insert, 40mm ceramic head with a +4 v40 sleeve.The reporting rep (who was not the rep present for the revision surgery) does not know at the time of report where the corrosion occurred.Update: "according to dr.(b)(6) the corrosion was noted on the back of the mdm liner, on the inner surface of the acetabular shell and in the joint fluid.The femoral head that was revised was delta ceramic.The explanted components were retained by the patient.I do not have any pictures of the explanted components as i was not present for the surgery.".
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a trident ii shell was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product remained implanted.-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 lot referenced.Conclusion: it was reported that patient had a revision due to corrosion noted on the back of the mdm liner, on the inner surface of the acetabular shell and in the joint fluid and pelvic osteolysis.The event could not be confirmed nor the exact cause be determined because insufficient information was provided.Additional information including device details, operative 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.
Event or Problem Description
It was reported the patient's left mako hip was revised due to corrosion, fluid buildup, metal debris, and massive pelvic osteolysis.An mdm metal liner, adm/ mdm poly insert, and femoral head of unknown composition were revised to a 40mm x3 insert, 40mm ceramic head with a +4 v40 sleeve.The reporting rep (who was not the rep present for the revision surgery) does not know at the time of report where the corrosion occurred.Update: "according to dr.(b)(6) the corrosion was noted on the back of the mdm liner, on the inner surface of the acetabular shell and in the joint fluid.The femoral head that was revised was delta ceramic.The explanted components were retained by the patient.I do not have any pictures of the explanted components as i was not present for the surgery.".

• Brand Name: TRIDENTII TRITANIUM CLUSTER54E
• 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-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 11139454
• Report Number: 0002249697-2021-00065
• Device Sequence Number: 3950223
• Product Code: LPH
• UDI-Device Identifier: 07613327344073
• UDI-Public: 07613327344073
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: 08/31/2023
• Device Model Number: 702-04-54E
• Device Catalogue Number: 702-04-54E
• Device Lot Number: 66916301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2018
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 113 KG