MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number SPT-090000S

Device Problem Device-Device Incompatibility (2919)

Patient Problems Foreign Body Reaction (1868); Metal Related Pathology (4530)

Event Date 12/04/2023

Event Type  Injury  

Manufacturer Narrative

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 excessive levels of cobalt in blood is considered to be under the scope of this recall.No further investigation is required.H3 other text : not available.

Event Description

Plaintiff alleges the right rejuvenate hip implanted on (b)(6), 2010, required a revision surgery on (b)(6), 2020, due to high co in his blood and altr.This pi is for right hip.

Event Description

Plaintiff alleges the right rejuvenate hip implanted on (b)(6) 2010, required a revision surgery on (b)(6) 2020, due to high co in his blood and altr.This pi is for right hip.

Manufacturer Narrative

Reported event: an event regarding abnormal ion levels involving a rejuvenate modular device was reported.The event was confirmed.Method & results: device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.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.Conclusions: the event was confirmed.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 abnormal ion level is considered to be under the scope of this recall.No further investigation is required.

• Brand Name: REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18333679
• MDR Text Key: 330545963
• Report Number: 0002249697-2023-01565
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/24/2024

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: 10/31/2014
• Device Catalogue Number: SPT-090000S
• Device Lot Number: MHKLW4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2009
• 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-2090-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention