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

Catalog Number	7236-2-848
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Noise, Audible (3273)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient received ltha.Wasn¿t happy with it so cup screw was removed and cup was revised.Mdm was implanted.Patient was out of state and dislocated.Patient was closed reduced.When the patient got home they noticed a sound coming from the hip.Didn¿t feel right.Came into the doctors clinic and the doctor noticed on x ray the mdm looked to be disassociated.We just revised the mdm and indeed it was disassociated.Update: sales rep confirmed the metal head disassociated from the adm liner.Update 09/september/2024: spoke to rep.Rep confirmed surgical protocol was followed exactly.Nothing unusual for assembly or implantation.The head is checked each time to ensure that it is properly seated.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving an adm liner was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned devices indicated the devices appeared undamaged.Dimensional inspection: dimensional inspection was performed on the features related to the articulation and fitment of the head in the liner.All features inspected were within specifications.-clinician review: a review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a primary left total hip arthroplasty since i was able to review the x-rays.I can also confirm that the patient had a revision of the acetabular cup since i was able to review post revision x-rays and the implant usage sheet.I was also able to review the operation note for the primary left total hip arthroplasty.A partial operation report was present for the surgery of (b)(6) 2024 that stated, "it was clear that the polyethylene had disassociated from the femoral head and the femoral head was articulating with the metallic liner." therefore, i can confirm the disassociation based upon the above quote.Root cause analysis: assuming that there was a disassociation of the femoral head from the adm liner, the root cause of this event cannot be determined with certainty.If it happened, the causes of disassociation of the head from the polyethylene acetabular liner are multifactorial.One cause could be surgical technique in the way that the implants are prepared and assembled.If the disassociation occurred directly after the closed reduction, it is possible that the reduction maneuver may have contributed to the uncoupling.I would not attribute any causality to the patient¿s lifestyle, activity level or bmi.The dislocations could be attributed to surgical technique, implant positioning, as well as patient factors such as lifestyle, activity level, bmi, and compliance with post operative instructions." -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 femoral head from the poly adm liner.Visual inspection of the returned devices indicated the devices appeared undamaged.Dimensional inspection was performed on the features related to the articulation and fitment of the head in the liner.All features inspected were within specifications.A review of the provided medical records by a clinical consultant confirmed the event and indicated the following: "assuming that there was a disassociation of the femoral head from the adm liner, the root cause of this event cannot be determined with certainty.If it happened, the causes of disassociation of the head from the polyethylene acetabular liner are multifactorial.One cause could be surgical technique in the way that the implants are prepared and assembled.If the disassociation occurred directly after the closed reduction, it is possible that the reduction maneuver may have contributed to the uncoupling.I would not attribute any causality to the patient¿s lifestyle, activity level or bmi.The dislocations could be attributed to surgical technique, implant positioning, as well as patient factors such as lifestyle, activity level, bmi, and compliance with post operative instructions.".
Event or Problem Description
Patient received ltha.Wasn¿t happy with it so cup screw was removed and cup was revised.Mdm was implanted.Patient was out of state and dislocated.Patient was closed reduced.When the patient got home they noticed a sound coming from the hip.Didn¿t feel right.Came into the doctors clinic and the doctor noticed on x ray the mdm looked to be disassociated.We just revised the mdm and indeed it was disassociated.Update: sales rep confirmed the metal head disassociated from the adm liner.Update 09/september/2024: spoke to rep.Rep confirmed surgical protocol was followed exactly.Nothing unusual for assembly or implantation.The head is checked each time to ensure that it is properly seated.

• Brand Name: RESTORATION ADM X3 INS 28/48
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 20230877
• Report Number: 0002249697-2024-01285
• Device Sequence Number: 8637933
• Product Code: JDI
• UDI-Device Identifier: 07613327315974
• UDI-Public: 07613327315974
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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 Catalogue Number: 7236-2-848
• Device Lot Number: 14683851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2023
• 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: 75 YR
• Patient Sex: Female