MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	7236-2-852
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	02/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt dislocated thr with mdm which also dissociated.Stem also removed and anteverted 10° and reinserted.The adm poly insert separated from the mdm metal liner and the femoral head separated from the adm poly insert.The metal liner was not revised.The stem was revised as the version needed anteverting by 10 degrees to prevent further dislocations.A new exeter stem was implanted.
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 similar events for the lot referenced.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.
Additional Manufacturer Narrative
An event regarding dislocation and disassociation involving an adm liner was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device has surface damage in the form of scratches and material delamination.Damage is consistent with explantation and time spent implanted.The head was not assembled in the adm liner upon return to site for inspection.-clinician review: a review with a clinical consultant indicated i can confirm that the patient underwent the three surgical procedures since i was able to review the original stryker stickers used in those surgeries.I did not however have the operation reports.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of hip dislocation with subsequent disassociation of an mdm articulation are multifactorial primary causes would be related to surgical technique including positioning of the implants, restoration of the soft tissue tension and leg lengths as well as proper closure of the soft tissue envelope.In this case the femoral stem was found to be mal positioned and had to be removed and placed 10° of anteversion.Unlikely contributing factors are the patient's lifestyle, activity level and bmi.I would not assign any causality to the implant regarding the disassociation unless some manufacturing defect was found upon inspection by stryker engineers.In this case i believe the disassociation most likely happened after the dislocation perhaps with an attempt to reduce it although there is no mention of that in the product summary.-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: visual inspection: visual inspection of the returned device indicated that the device has surface damage in the form of scratches and material delamination.Damage is consistent with explantation and time spent implanted.The head was not assembled in the adm liner upon return to site for inspection.-clinician review: a review with a clinical consultant indicated' i can confirm that the patient underwent the three surgical procedures since i was able to review the original stryker stickers used in those surgeries.I did not however have the operation reports.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of hip dislocation with subsequent disassociation of an mdm articulation are multifactorial primary causes would be related to surgical technique including positioning of the implants, restoration of the soft tissue tension and leg lengths as well as proper closure of the soft tissue envelope.In this case the femoral stem was found to be mal positioned and had to be removed and placed 10° of anteversion.Unlikely contributing factors are the patient's lifestyle, activity level and bmi.I would not assign any causality to the implant regarding the disassociation unless some manufacturing defect was found upon inspection by stryker engineers.In this case i believe the disassociation most likely happened after the dislocation perhaps with an attempt to reduce it although there is no mention of that in the product summary.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
No new information.

• Brand Name: RESTORATION ADM X3 INS 28/52
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21593119
• Report Number: 0002249697-2025-00303
• Device Sequence Number: 21064124
• Product Code: MEH
• UDI-Device Identifier: 07613327315967
• UDI-Public: 07613327315967
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: 7236-2-852
• Device Lot Number: 90142501
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Unknown