MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LRG TAP PRI MOD NCK 8DEG 38MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number NLV-380800Y

Device Problem Device-Device Incompatibility (2919)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Metal Related Pathology (4530)

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.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 pain and elevated metal ion levels are considered to be under the scope of this recall.No further investigation is required.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Not returned.

Event Description

Plaintiff alleges the left rejuvenate hip implanted on (b)(6) 2009 failed causing pain and elevated metal ion levels.Plaintiff has not yet scheduled revision surgery.Update: it was reported that the patient's left hip was revised due to a femoral periprosthetic fracture.A rejuvenate modular stem construct, 40 +0 head and 40f neutral liner were revised.Rep confirmed there are no allegations against any of the revised implants.

Manufacturer Narrative

Reported event: an event regarding pain and elevated metal ions involving an unknown rejuvenate modular device was reported.The event was confirmed.Method & results: device evaluation and results: device evaluation was not performed as no devices were received.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: there have been 03 other event reported for the lot code.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 pain and elevated metal ions is considered to be under the scope of this recall.No further investigation is required.

Event Description

Plaintiff alleges the left rejuvenate hip implanted on (b)(6) 2009 failed causing pain and elevated metal ion levels.Plaintiff has not yet scheduled revision surgery.Update: it was reported that the patient's left hip was revised due to a femoral periprosthetic fracture.A rejuvenate modular stem construct, 40 +0 head and 40f neutral liner were revised.Rep confirmed there are no allegations against any of the revised implants.

• Brand Name: LRG TAP PRI MOD NCK 8DEG 38MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12444877
• MDR Text Key: 270482074
• Report Number: 0002249697-2021-01525
• 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,Followup
• Report Date: 05/03/2022

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: Health Professional
• Device Expiration Date: 09/27/2012
• Device Catalogue Number: NLV-380800Y
• Device Lot Number: 23326701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2007
• 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): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 116 KG