MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN REJUVENATE/ABGII MODULAR NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNK_SHC

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

The patient has not reported any symptoms.Should additional information become available, a follow up report will be submitted.A voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.Not returned.

Event Description

It was reported that the patient is asymptomatic.This patient has not reported any symptoms and was implanted with devices in scope of ra 2012-067.

Manufacturer Narrative

No device failure modes or patient harms were identified in the reported event.Ncr was initiated on (b)(6) 2012 because the occurrence rate for adverse local tissue reaction (altr) specified in the risk management files for the abgii modular hip system was exceeded.Given the potential risk of fretting and corrosion with these devices, voluntary product recall was issued.H3 other text: device not available.

Event Description

It was reported that the patient is asymptomatic.This patient has not reported any symptoms and was implanted with devices in scope of ra 2012-067.

• Brand Name: UNKNOWN REJUVENATE/ABGII MODULAR NECK
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11597170
• MDR Text Key: 243909848
• Report Number: 0002249697-2021-00578
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2090-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention