MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number SPT-110000S

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

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 05/03/2013

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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 elevated levels of cobalt and chromium revealed in bloodwork 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 7/22/2020: plaintiff was implanted with a rejuvenate modular hip stem on his left hip on or about (b)(6) 2011.It is further alleged that the plaintiff had the left hip stem at issue explanted on (b)(6) 2019 due to elevated levels of cobalt an chromium revealed in bloodwork.

Manufacturer Narrative

An event regarding elevated metal ions involving a 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 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 no 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 elevated metal ions is considered to be under the scope of this recall.No further investigation is required.

Event Description

It was reported that the patient is asymptomatic.Additional information received from legal on 7/22/2020: plaintiff was implanted with a rejuvenate modular hip stem on his left hip on or about (b)(6) 2011.It is further alleged that the plaintiff had the left hip stem at issue explanted on (b)(6) 2019 due to elevated levels of cobalt an chromium revealed in bloodwork.

• Brand Name: REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 11
• 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
• MDR Report Key: 10401520
• MDR Text Key: 202740007
• Report Number: 0002249697-2020-01661
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K092561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: SPT-110000S
• Device Lot Number: MHR791
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2090-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention