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

Model Number 1236-2-852

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 08/01/2019

Event Type  Injury  

Event Description

Patient had a bilateral stryker hip replacement on (b)(6), 2018 with trident product.In (b)(6) 2018, patient noticed instability in right hip.Patient was revised in (b)(6) 2019 due to broken poly liner.Patient mentioned "metal on metal" and alleges high levels of chromium and cobalt.

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.

Manufacturer Narrative

This report is being closed as a duplicate of fda ref 0002249697-2022-00864.

Event Description

Patient had a bilateral stryker hip replacement on (b)(6), 2018 with trident product.In (b)(6) 2018, patient noticed instability in right hip.Patient was revised in (b)(6) 2019 due to broken poly liner.Patient mentioned "metal on metal" and alleges high levels of chromium and cobalt.

• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14750392
• MDR Text Key: 294585792
• Report Number: 0002249697-2022-00874
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540638991
• UDI-Public: 04546540638991
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1236-2-852
• Device Catalogue Number: 1236-2-852
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 78 KG