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

Catalog Number SPT-090000S

Device Problem Device-Device Incompatibility (2919)

Patient Problems Pain (1994); Local Reaction (2035); Metal Related Pathology (4530)

Event Date 04/24/2013

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding abnormal ion level and altr involving a rejuvenate modular device was reported.The event was confirmed.Device evaluation and results: device evaluation was not performed as no devices were received.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: 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 and altr is considered to be under the scope of this recall.No further investigation is required.Device not returned.

Event Description

It was reported that the patient is asymptomatic.Additional information received from legal on 3/10/2016: plaintiff alleges the right rejuvenate hip implanted on or about (b)(6) 2010 failed causing pain and elevated metal ion levels.Plaintiff has not yet scheduled revision surgery on either hip.Suit filed in (b)(6).Update 12/january/2021 wg: as reported by rep: "dr.Performed a right hip revision due to altr.No more information is available per doctor." spoke to rep.A rejuvenate modular stem construct, biolox head, and x3 insert were revised.Rep provided a primary usage report and confirmed there are no allegations against the revised head or liner.

• Brand Name: REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 11271936
• MDR Text Key: 230034131
• Report Number: 0002249697-2021-00204
• 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
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: SPT-090000S
• Device Lot Number: MHNTPA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2010
• 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: 75 YR
• Patient Weight: 75