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

Catalog Number NLS-341600P

Device Problems Corroded (1131); Degraded (1153)

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

Event Date 03/22/2016

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, 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 revision is considered to be under the scope of this recall.No further investigation is required.Device not available.

Event Description

Information received from broadspire: it was reported that the patient is asymptomatic.Update 28/july/2020 wg: it was reported that the patient's left hip was revised due to trunnionosis at the head/ neck junction and corrosion at the head/ neck and stem/ neck junctions.Patient was revised to a restoration ha stem and ceramic head.Rep confirmed that the liner and shell were not revised.No further information will be released by the hospital or surgeon.

• Brand Name: LRG TAP PRI MOD NCK 16DEG 34MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; IE NA
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; IE NA
• Manufacturer Contact: daniela davila ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10451480
• MDR Text Key: 204345458
• Report Number: 0002249697-2020-01706
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/27/2014
• Device Catalogue Number: NLS-341600P
• Device Lot Number: 31781801
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2009
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR