MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Model Number	626-00-48G
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Ambulation or Postural Difficulties (2544)
Date of Event	12/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: patient had surgery on the 22nd of december for caput necroses.Had traumatic fall on the 24th of december.Xray discovered luxation.Revision surgery planned.
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.Device not returned.
Additional Manufacturer Narrative
Update to event description changed reportable device.An event regarding disassociation involving an adm liner was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the rim of the inner diameter of the liner is slightly deformed.Minor scratches are observed in the inner diameter and along the outer surface of the liner.The observed surface characteristics appear consistent with damage sustained from the dislocation event and/or contact with explantation tooling.-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 adm liner from a metal head (non-stryker).Visual inspection of the returned device indicated that the rim of the inner diameter of the liner is slightly deformed.Minor scratches are observed in the inner diameter and along the outer surface of the liner.The observed surface characteristics appear consistent with damage sustained from the dislocation event and/or contact with explantation tooling.It was reported that the patient suffered a traumatic fall that led to the event, and this is likely the root cause.Additional information such as pre- and post-operative x-ray images, primary and revision operation reports, and patient history are needed to confirm the event.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The following was reported: patient had surgery on the 22nd of december for caput necroses.Had traumatic fall on the 24th of december.Xray discovered luxation.Revision surgery planned.Update: adm liner and non-stryker metal head were revised as these devices were returned to stryker for evaluation.Revision date is unknown.It is unknown at this time if any other devices were revised.

• Brand Name: RESTORATION ADM X3 INS 28/54
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13311635
• Report Number: 0002249697-2022-00111
• Device Sequence Number: 4944830
• Product Code: LZO
• UDI-Device Identifier: 04546540639004
• UDI-Public: 04546540639004
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K093644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2022

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 Model Number: 626-00-48G
• Device Catalogue Number: 1236-2-854
• Device Lot Number: 507516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2021
• 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: 74 YR
• Patient Sex: Male