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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 11/18/2023

Event Type  Injury  

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.H3 other text : device not returned to the manufacturer.

Event Description

Patient with mdm insert dislocated at home approx 2 months post op and had to have his hip revised.Update as per sales rep: the head came dislocated (disassociated) from the poly.It was still on the stem.There was a fall involved.Right side.

• Brand Name: RESTORATION ADM X3 INS 28/52
• Type of Device: 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: 18339950
• MDR Text Key: 330667096
• Report Number: 0002249697-2023-01567
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07613327315967
• UDI-Public: 07613327315967
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 7236-2-852
• Device Lot Number: 88041401
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male