MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN REJUVENATE MODULAR STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_JR

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

Patient Problems Inflammation (1932); Reaction (2414)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.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 is considered to be under the scope of this recall.No further investigation is required.

Event Description

Information received from legal: the plaintiff alleges that the right rejuvenate modular hip stem implanted on (b)(6) 2011 failed due to elevated levels of cobalt and chromium.Revision not yet scheduled.

Event Description

Information received from legal : the plaintiff alleges that the right rejuvenate modular hip stem implanted on (b)(6) 2011 failed due to elevated levels of cobalt and chromium.Revision not yet scheduled.

Manufacturer Narrative

Reported event: an event regarding abnormal ion level 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 could not be performed as the reported device was not properly identified.Complaint history review: a search of the complaint databases could not be performed as the reported device was not properly identified.Similar events have occurred for the rejuvenate modular product family.These events were determined to be associated with (b)(4).Conclusions voluntary recall (b)(4) 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: UNKNOWN REJUVENATE MODULAR STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10125129
• MDR Text Key: 194317415
• Report Number: 0002249697-2020-01041
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2090-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention