MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number	1236-2-848
Medical Device Problem Codes	Degraded (1153); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This pi is event 2.Second revision surgery on (b)(6) 2023.Bone head center position was obviously wrong on the reline and the sliding surface was moving strangely.Surgeon found that the adm insert was deformed/worn during surgery.Finished the revision surgery with competitor device on (b)(6) 2023.
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.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.Device not returned to the manufacturer.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation and wear involving an adm liner was reported.The event was confirmed via evaluation of the returned device and clinician review of the provided medical records.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.The observed surface characteristics appear consistent with damage sustained from the dislocation event and/or the explantation attempt.This damage is also visible in the intraoperative photo that was provided.-clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion/assessment: revision surgery performed first for mom-altr then for a presumed intra-prosthetic dislocation or subluxation.Event confirmation: eccentric position of the femoral head can be confirmed from the x-rays.The implants and reasons leading to the event cannot be confirmed.Root cause: the root cause cannot be confirmed." -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 "the sliding surface moving strangely." wear/deformation of the adm poly liner was also observed intra-operatively.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.The observed surface characteristics appear consistent with damage sustained from the dislocation event and/or the explantation attempt.This damage is also visible in the intraoperative photo that was provided.A review of the provided medical information by a clinical consultant indicated: "conclusion/assessment: revision surgery performed first for mom-altr then for a presumed intra-prosthetic dislocation or subluxation.Event confirmation: eccentric position of the femoral head can be confirmed from the x-rays.The implants and reasons leading to the event cannot be confirmed." the intraoperative photo provided shows the adm liner articulating within part number 172501, metal on metal cup 50mm cup for 42mm head.The surgical protocol relevant to the adm liner, mdm-sp-1_rev-3_29426, does not reference part number 172501 as a compatible device.Mdm liner 626-00-42e is listed as the compatible device in which adm liner 1236-2-848 is intended to articulate.It is likely that the event is the result of off label use, but this cannot be confirmed without documentation regarding the instructions for use / surgical protocol for part number 172501.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
This pi is event 2.Second revision surgery on (b)(6) 2023.Bone head center position was obviously wrong on the reline and the sliding surface was moving strangely.Surgeon found that the adm insert was deformed/worn during surgery.Finished the revision surgery with competitor device on (b)(6) 2023.

• Brand Name: RESTORATION ADM X3 INS 28/48
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16961099
• Report Number: 0002249697-2023-00564
• Device Sequence Number: 5580464
• Product Code: MEH
• UDI-Device Identifier: 04546540638977
• UDI-Public: 04546540638977
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2023

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 Expiration Date: 02/29/2024
• Device Model Number: 1236-2-848
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 70602401
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2019
• 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 Age: 77 YR
• Patient Sex: Female
• Patient Weight: 50 KG