MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LRG TAP PRI MOD NCK 8DEG 34MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number NLV-340800G

Device Problems Device-Device Incompatibility (2919); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been two other similar events for the lot referenced. It was noted that the device is not available for evaluation. Should additional information become available, 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 pain is considered to be under the scope of this recall. No further investigation is required.

Event Description

Per medical records in pi, rejuvenate stem and neck was revised to restoration modular stem and body due to metal on metal reaction. Update: - (b)(6) 2013 rejuvenate modular hip was revised to restoration modular due to increasing pain and increased metal ions.

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been two other similar events for the lot referenced. It was noted that the device is not available for evaluation. Should additional information become available, 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 pain is considered to be under the scope of this recall. No further investigation is required.

Event Description

Per medical records in pi, rejuvenate stem and neck was revised to restoration modular stem and body due to metal on metal reaction. Update: - (b)(6) 2013 rejuvenate modular hip was revised to restoration modular due to increasing pain and increased metal ions.

• Brand Name: LRG TAP PRI MOD NCK 8DEG 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 13169363
• MDR Text Key: 286044469
• Report Number: 0002249697-2022-00021
• 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

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/2016
• Device Catalogue Number: NLV-340800G
• Device Lot Number: 37865501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2011
• 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 Treatment Data

Date Received: 01/05/2022 Patient Sequence Number: 1