MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ADM/MDM POLY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number UNK_SHC

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 01/06/2022

Event Type  Injury  

Event Description

As reported by the rep: "we removed an mdm construct and replaced with a constrained liner.Instability was the issue." it was reported through the submission of a revision implant sheet that the patient's right hip was revised.Comparing information with the patient's previous revision, an mdm metal liner, adm/ mdm poly insert, and femoral head were revised to a 0° constrained liner and 22.2 +8 v40 femoral head.

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

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.

Event Description

As reported by the rep: "we removed an mdm construct and replaced with a constrained liner.Instability was the issue." it was reported through the submission of a revision implant sheet that the patient's right hip was revised.Comparing information with the patient's previous revision, an mdm metal liner, adm/ mdm poly insert, and femoral head were revised to a 0° constrained liner and 22.2 +8 v40 femoral head.

• Brand Name: UNKNOWN ADM/MDM POLY INSERT
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13392137
• MDR Text Key: 285625730
• Report Number: 0002249697-2022-00142
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 77
• Patient Sex: Female
• Patient Weight: 62 KG