MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALL POLY CONSTRAINED INSERT 46MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	69-2246
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	07/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Poly constrained liner has luxated and was removed.
Event or Problem Description
Poly constrained liner has luxated and was removed.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a trident liner was reported.The event was confirmed through clinician review and product evaluation.Method & results: -device evaluation and results: visual inspection of the returned device indicates the constraint liner had extensive damage.There is damage present on the rim of the liner that is consistent with delamination and material loss.The metal ring is also deformed.The uhr head component has disassembled from the outer poly shell of the constrained liner.Scratches are visible on the outer metal surface of the head consistent with explantation and/or damage from the disassembly in the patient.-clinician review: a review of medical records with a clinical consultant indicated " conclusion/assessment: no medical records were provided for review.A series of x-rays show a dislocation of a tha from a constrained cemented all polyethylene liner.Event confirmation: a dislocation can be confirmed from a constrained liner.A second dislocation cannot be confirmed.Removal of the liners cannot be confirmed.Root cause: a root cause for the dislocation cannot be ascertained without additional medical records." -device history review: a review of the device history records could not be performed as lot code information was unknown.-complaint history review: a complaint history review could not be performed as lot code information was unknown.Conclusion: visual inspection of the returned device indicates the constraint liner had extensive damage.There is damage present on the rim of the liner that is consistent with delamination and material loss.The metal ring is also deformed.The uhr head component has disassembled from the outer poly shell of the constrained liner.Scratches are visible on the outer metal surface of the head consistent with explantation and/or damage from the disassembly in the patient.A review of medical records with a clinical consultant indicated " conclusion/assessment: no medical records were provided for review.A series of x-rays show a dislocation of a tha from a constrained cemented all polyethylene liner.Event confirmation: a dislocation can be confirmed from a constrained liner.A second dislocation cannot be confirmed.Removal of the liners cannot be confirmed.Root cause: a root cause for the dislocation cannot be ascertained without additional medical records." no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ALL POLY CONSTRAINED INSERT 46MM
• 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17403965
• Report Number: 0002249697-2023-00845
• Device Sequence Number: 12252712
• Product Code: KWZ
• UDI-Device Identifier: 07613327025453
• UDI-Public: 07613327025453
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2023

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: 69-2246
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown