MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LRG TAP PRI MOD NCK 0DEG 30MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number NLS-300000B

Device Problem Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2022

Event Type  Injury  

Event Description

Claimant underwent right total hip arthroplasty on (b)(6) 2011 and was implanted with the following components: rejuvenate spt modular stem #7; rejuvenate modular neck 127°/132° neck angle; lfit anatomic v40 femoral head; trident x3 10° polyethylene insert; trident psl ha cluster acetabular shell.She was revised on (b)(6) 2021 due to alleged cobalt and chromium toxicity.

Manufacturer Narrative

Reported event: an event regarding abnormal ion levels involving a rejuvenate 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: review of device history records found the devices in the reported lot were accepted into final stock with no reported discrepancies.Complaint history review: the complaint databases show there have been other events for the reported lot.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: LRG TAP PRI MOD NCK 0DEG 30MM
• 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: 13382916
• MDR Text Key: 287610955
• Report Number: 0002249697-2022-00136
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: NLS-300000B
• Device Lot Number: 37354801
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2011
• 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-2090-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention