MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALL POLY CONSTRAINED INSERT 56MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	69-3256
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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
The following was reported: "cemented constrained cup dislocated following movement in patients bed.Cemented constrained cup removed and replaced with a ras shell, when impacting the 58mm ras shell the surgeon then had a fracture in the medial wall so shell was upsized to 62mm.Left hip".
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: the reported devices were not returned; however, photographs were provided for review.The photographs show a recently explanted all-poly constrained liner.The inner bipolar component has been removed from the outer liner.The ceramic head remains assembled to the bipolar component.The event cannot be confirmed from the photographs, as it cannot be confirmed that the disassociation occurred in-situ without x-ray images.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.Conclusions: it was reported that the patient was revised due to disassociation of the bipolar component from the all-poly constrained liner.The reported devices were not returned; however, photographs were provided for review.The photographs show a recently explanted all-poly constrained liner.The inner bipolar component has been removed from the outer liner.The ceramic head remains assembled to the bipolar component.The event cannot be confirmed from the photographs, as it cannot be confirmed that the disassociation occurred in-situ without x-ray images.Further information such as return of the device, pre- and post-operative x-rays and the primary/revision operative reports 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.
Event or Problem Description
The following was reported: "cemented constrained cup dislocated following movement in patients bed.Cemented constrained cup removed and replaced with a ras shell, when impacting the 58mm ras shell the surgeon then had a fracture in the medial wall so shell was upsized to 62mm.Left hip".Update: the inner bipolar component dislocated from the outer component.

• Brand Name: ALL POLY CONSTRAINED INSERT 56MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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: 19420086
• Report Number: 0002249697-2024-00812
• Device Sequence Number: 8747552
• Product Code: KWZ
• UDI-Device Identifier: 07613327025606
• UDI-Public: 07613327025606
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 01/31/2026
• Device Catalogue Number: 69-3256
• Device Lot Number: 6T01LH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2021
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 127 KG