MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LRG TAP PRI MOD NCK 16DEG 34MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number NLS-341600P

Device Problems Corroded (1131); Device-Device Incompatibility (2919)

Patient Problem Metal Related Pathology (4530)

Event Date 06/01/2014

Event Type  Injury  

Event Description

It was reported that the patient had cobalt level 1.2 states high - hip has popped out of socket at times.High level of cobalt, dislocation, corrosion, revision.It was reported that the patient's right hip was revised due to recurrent dislocations.Intra-operatively, corrosion was noted at both the stem-neck interface and head-trunnion interface.All components were removed.Rep provided pictures and confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

An event regarding abnormal ion level and corrosion involving a rejuvenate modular device was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection of images note blood drops and black material on neck surface.Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: the complaint databases show there have not 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 high level of cobalt is considered to be under the scope of this recall.No further investigation is required.Not returned to the manufacturer.

• Brand Name: LRG TAP PRI MOD NCK 16DEG 34MM
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16406767
• MDR Text Key: 309881090
• Report Number: 0002249697-2023-00175
• 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,Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: NLS-341600P
• Device Lot Number: 31715101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2010
• 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-2090-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male