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

Catalog Number	1236-2-848
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: revision surgery today of a left total hip.The revision today was secondary to dislocation.The dislocation (disassociation) occurred between the ceramic head and poly insert.The mdm liner, insert, head and cup were removed.A new cup was placed with four screws, a constrained liner and new head.No further information is available from the doctor or hospital." surgeon felt that the shell position was too vertical, and revised the shell and a screw.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.H3 other text : not returned.
Event or Problem Description
As reported: revision surgery today of a left total hip.The revision today was secondary to dislocation.The dislocation (disassociation) occurred between the ceramic head and poly insert.The mdm liner, insert, head and cup were removed.A new cup was placed with four screws, a constrained liner and new head.No further information is available from the doctor or hospital." surgeon felt that the shell position was too vertical, and revised the shell and a screw.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving an adm liner was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: this patient underwent a primary total hip arthroplasty approximately 13 years ago.She underwent a revision procedure in (b)(6) 2022 and another revision procedure for dislocation in (b)(6) 2023.I can confirm that the patient had a total hip arthroplasty and a revision of that arthroplasty since i was able to review x-rays.The root cause of this event cannot be determined with certainty.The causes of revision for dislocation are multifactorial including surgical technique, patient factors including activity level and bmi and lifestyle considerations, soft tissue stretching after 10 years of use, and possibly implant factors if the ceramic head dislocated from the polyethylene of an mdm prosthesis.The explanted prosthesis should be submitted to stryker engineers for evaluation and examination.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 dislocation.A review of the provided medical records by a clinical consultant indicated: this patient underwent a primary total hip arthroplasty approximately 13 years ago.She underwent a revision procedure in (b)(6) 2022 and another revision procedure for dislocation in (b)(6) 2023.I can confirm that the patient had a total hip arthroplasty and a revision of that arthroplasty since i was able to review x-rays.The root cause of this event cannot be determined with certainty.The causes of revision for dislocation are multifactorial including surgical technique, patient factors including activity level and bmi and lifestyle considerations, soft tissue stretching after 10 years of use, and possibly implant factors if the ceramic head dislocated from the polyethylene of an mdm prosthesis.The explanted prosthesis should be submitted to stryker engineers for evaluation and examination.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 17648751
• Report Number: 0002249697-2023-00965
• Device Sequence Number: 20636217
• Product Code: MEH
• UDI-Device Identifier: 04546540638977
• UDI-Public: 04546540638977
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K093644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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: 05/31/2026
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 85630501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2021
• 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: 76 YR
• Patient Sex: Female