MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS CORK LRG TAP PRI MOD NCK 0DEG 38MM; IMPLANT

Catalog Number NLS-380000B

Device Problems Nonstandard Device (1420); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Toxicity (2333); Osteopenia/ Osteoporosis (2651); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/03/2010

Event Type  Injury  

Event Description

It was reported that pt complains of extreme pain and soreness in left hip since the surgery.His mobility has also decreased.Surgeon has stated that both hips need to be replaced due to deterioration, bone loss, and muscle loss.Pt was told by his surgeon to call stryker to have this on record.Update: components were explanted due to adverse local tissue reaction.Restoration modular was used as replacement device.Revision surgery was required.Cobalt-4.6, chromium-6.0.

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock met specifications.The complaint history review indicated that there have been similar events for the reported family.The event was confirmed.A voluntary recall (b)(4) was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported event is considered to be under the scope of this recall.

• Brand Name: LRG TAP PRI MOD NCK 0DEG 38MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS CORK; carrigtwohill, cork ; EI
• Manufacturer (Section G): STRYKER ORTHOPAEDICS CORK; ida industrial estate; carrigtwohill, cork ; EI
• Manufacturer Contact: kayla navedo ; 325 corporate dr.; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3625048
• MDR Text Key: 4135326
• Report Number: 9616680-2014-00301
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2012

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: Other
• Device Expiration Date: 06/30/2014
• Device Catalogue Number: NLS-380000B
• Device Lot Number: 29589702
• Other Device ID Number: 0906KM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2014
• Initial Date FDA Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: RA 2012-067
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 113