MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	500-03-48C
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
On (b)(6), 2017, primary tha surgery was performed and the tritanium cup was implanted in the left hip of the female patient.On (b)(6), 2023, central migration was confirmed.The cup was about to go through the inner plate of the hip joint and the patient complained of pain.
Additional Manufacturer Narrative
An event regarding subsidence involving an 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 remains implanted.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: catalog: 500-03-46b, , lot: m3460y.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.500-03-48c, , lot: vt5yjn 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 lots referenced.Conclusions: it was reported that central migration of the shell was noted and that the patient complaint of pain.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, 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.The patient has bilateral tha's; this event is for the left hip.The hospital is unsure which device is implanted on the left hip and provide us with both devices information; therefore, an investigation for each device has been completed under this complaint.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
On (b)(6) 2017, primary tha surgery was performed and the tritanium cup was implanted in the left hip of the female patient.On (b)(6) 2023, central migration was confirmed.The cup was about to go through the inner plate of the hip joint and the patient complained of pain.

• Brand Name: PRIMARY TRITANIUM HEMI SOLIDBACK CUP 48MM
• 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 NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17983422
• Report Number: 0002249697-2023-01240
• Device Sequence Number: 5993099
• Product Code: LPH
• UDI-Device Identifier: 07613327039993
• UDI-Public: 07613327039993
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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 Catalogue Number: 500-03-48C
• Device Lot Number: M3460Y, VT5YJN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Female