MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRIT HEMI SOLIDBACK CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	500-03-58F
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a trident shell was reported.The event was confirmed via clinician review of the provided medical records.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 information by a clinical consultant indicated: "there is evidence of loss of fixation of the acetabular component with revision to a pressfit cup with bone graft and mesh in the supra- acetabular region.There is also evidence of stem fracture through the trunnion.Loss of fixation of a pressfit acetabular component and subsequent fracture of the trunnion of the femoral component is confirmed.The root cause of these mechanical failures cannot be determined from the limited documentation provided." 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 shell.A review of the provided medical information by a clinical consultant indicated: "there is evidence of loss of fixation of the acetabular component with revision to a pressfit cup with bone graft and mesh in the supra- acetabular region.There is also evidence of stem fracture through the trunnion.Loss of fixation of a pressfit acetabular component and subsequent fracture of the trunnion of the femoral component is confirmed.The root cause of these mechanical failures cannot be determined from the limited documentation provided." 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
It was reported the patient had a hip cup revision due to aseptic loosening.

• Brand Name: PRIMARY TRIT HEMI SOLIDBACK CUP 58MM
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 19202138
• Report Number: 0002249697-2024-00659
• Device Sequence Number: 18154906
• Product Code: LPH
• UDI-Device Identifier: 07613327040050
• UDI-Public: 07613327040050
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K081171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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: 06/30/2015
• Device Catalogue Number: 500-03-58F
• Device Lot Number: MJKN2M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2010
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 150 KG