MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRIT HEMI CLUSTER HOLE CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	502-03-50D
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Metal Related Pathology (4530)
Date of Event	07/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: "this product inquiry concerns a female patient who underwent a primary cementless total hip arthroplasty in 2009 and then developed what is described as bone resorption around the femur and acetabulum although that was not corroborated in the revision operation report.Patient also developed elevated metal ions and underwent revision surgery on (b)(6) 2018.At that time the revision was carried out with a competitor implants and stryker cables.While i was not able to review the operation report of the primary total hip arthroplasty, i was able to review the original stryker stickers so i can confirm that the procedure was done.I also can confirm that the revision procedure was done because i was able to review the operation report.The root cause of revision surgery for bone resorption and elevated metal ions is multifactorial including surgical technique factors including preparation of the femoral head and trunnion prior to insertion, patient activity level and bmi, and 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 both the femoral and acetabular components as well as elevated cobalt levels in her blood.A review of the provided medical records by a clinical consultant was unable to confirm the event.Further information such as pathology reports, and the pre- and post-operative x-rays 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : not returned to the manufacturer.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit v40 femoral head on her right hip on or about (b)(6) 2009.It is further alleged that she developed bone resorption at her acetabulum and proximal femur as well as elevated cobalt levels in her blood and based upon these findings she was revised on (b)(6) 2018.

• Brand Name: PRIMARY TRIT HEMI CLUSTER HOLE CUP 50MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 19264255
• Report Number: 0002249697-2024-00699
• Device Sequence Number: 16786399
• Product Code: JDI
• UDI-Device Identifier: 07613327040135
• UDI-Public: 07613327040135
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

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: 12/31/2013
• Device Catalogue Number: 502-03-50D
• Device Lot Number: METD65
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2008
• 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: 66 YR
• Patient Sex: Female