MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_ ABGII MODULAR NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number UNK_SHC

Device Problems Device-Device Incompatibility (2919); Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 05/04/2020

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.

Event Description

Information received from legal: plaintiff was implanted with a right abg ii modular hip stem on (b)(6) 2012.Its further alleged that the plaintiff had blood work that revealed elevated levels of cobalt and chromium in bloodwork.Plaintiff has not yet been revised.

Event Description

Information received from legal :plaintiff was implanted with a right abg ii modular hip stem on (b)(6) 2012.Its further alleged that the plaintiff had blood work that revealed elevated levels of cobalt and chromium in bloodwork.Plaintiff has not yet been revised.

Manufacturer Narrative

Reported event: an event regarding abnormal ion level involving a abgii modular device was reported.The event was confirmed.Method & results: device evaluation and results: device evaluation was not performed as no devices were received.Device history review: not performed as no lot was provided.Complaint history review: similar events have occurred for the catalog number and product family.These events were determined to be associated with ra 2012-067.Conclusions: voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported abnormal ion level is considered to be under the scope of this recall.No further investigation is required.

• Brand Name: UNKNOWN_ ABGII MODULAR NECK
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10090757
• MDR Text Key: 192141338
• Report Number: 0002249697-2020-00978
• 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: 07/14/2020

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: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 06/23/2020
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2089-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention