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

Catalog Number 4845-4-105

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Reaction (2414)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

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. 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. 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 elevated levels of cobalt and chromium is considered to be under the scope of this recall. No further investigation is required.

Event Description

After the procedure with abgii modular, metallosis diagnosed in (b)(6) 2014 and therefore the need for further revision, explant and replacement of the prosthesis.

• Brand Name: ABGII. MODULAR STEM
• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; GB WD6 3SJ ; 2018315000
• MDR Report Key: 10269573
• MDR Text Key: 198865264
• Report Number: 0002249697-2020-01419
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K092406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 4845-4-105
• Device Lot Number: G2977582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2089-2012

Patient Treatment Data

Date Received: 07/14/2020 Patient Sequence Number: 1