MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LRG TAP PRI MOD NCK 0DEG 38MM; HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE

Catalog Number NLS-380000B

Device Problems Corroded (1131); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 06/03/2018

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received will be provided in a supplemental report.A voluntary recall (b)(4) was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.Not returned.

Event Description

Patient was out of the country and required transport back to the us for treatment.Revision hip surgery to remove rejuvenate stem, femoral head and trident polyethylene liner.Rejuvenate neck was separated from stem.Head and neck were still a unit.Re-implant with restoration modular stem and body, biolox femoral head, mdm liner and dall miles cables.Update: as reported in how was issue noticed: patient was sitting in an adirondack style chair.When he rose from the chair he felt a ¿give¿ in his hip and could not put full weight on his leg.Patient reported to his physician.

Manufacturer Narrative

An event regarding revision due to corrosion and disassociation of neck from stem involving a rejuvenate modular device was reported.A material analysis conducted on the returned device confirmed the corrosion.Method & results: device evaluation and results: material analysis was performed on the returned devices states : "the taper lock region of the neck trunnion displayed damage surface morphologies consistent with micro-motion.Eds showed the neck base alloy was consistent with astm f1537 alloy and the discoloration on the taper lock region on the neck trunnion was consistent with a corrosion product, the stem base alloy, and biological material.The micro-motion and corrosion observed on the taper lock region of the neck trunnion is consistent with a mechanically-assisted corrosion process taking place.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." 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.

Event Description

Patient was out of the country and required transport back to the us for treatment.Revision hip surgery to remove rejuvenate stem, femoral head and trident polyethylene liner.Rejuvenate neck was separated from stem.Head and neck were still a unit.Re-implant with restoration modular stem and body, biolox femoral head, mdm liner and dall miles cables.Update: as reported in how was issue noticed: patient was sitting in an adirondack style chair.When he rose from the chair he felt a ¿give¿ in his hip and could not put full weight on his leg.Patient reported to his physician.Update: "the taper lock region of the neck trunnion displayed damage surface morphologies consistent with micro-motion.The discoloration on the taper lock region on the neck trunnion was consistent with a corrosion product, the stem base alloy, and biological material.The micro-motion and corrosion observed on the taper lock region of the neck trunnion is consistent with a mechanically-assisted corrosion process taking place.Damage was observed on the distal surface of the insert, consistent with impingement.".

• Brand Name: LRG TAP PRI MOD NCK 0DEG 38MM
• Type of Device: HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7659469
• MDR Text Key: 113054336
• Report Number: 0002249697-2018-02046
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K092561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

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: No Information
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: NLS-380000B
• Device Lot Number: 32791602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2089/2090-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 132