MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN REJUVENATE STEM SIZE 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number UNK_JR

Device Problem Device-Device Incompatibility (2919)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530)

Event Date 02/20/2015

Event Type  Injury  

Manufacturer Narrative

An event regarding revision due to pain and excessive metal ions in blood 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 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 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 revision due to pain and excessive metal ions in blood is considered to be under the scope of this recall.No further investigation is required.

Event Description

It was reported surgeon revised patient's left rejuvenate hip due to elevated cobalt and pain.

Event Description

It was reported surgeon revised patient's left rejuvenate hip due to elevated cobalt and pain.

Manufacturer Narrative

Reported event: an event regarding altr involving a rejuvenate modular device was reported.The event was confirmed based on medical review.  method & results: -device evaluation and results: device evaluation was not performed as no devices were received.Clinician review: a review of the provided medical records by a clinical consultant indicated: relevant clinical history: (b)(6) 2015: handwritten op plan note, outlined procedure with potential to change cup, and use of restoration modular stem.(b)(6) 2015: implant record: dall-miles cables x5, 56mm trident psl shell, 2 screws 30mm, 35mm, restoration mod conical stem 14mmxl55mm, med trochanteric gripper 150mm, 36mm id x3 polyethylene, 23mm +0 v40 modular body, 36mm +0 biolox head.Adverse event identified.There were multiple adverse events and noted in the series of pi reports.First was an apparent response to metal ions likely emanating from the modular interface of the rejuvenate stem (a known and documented problem).The tissue and intraoperative findings were however not provided.The second potential adverse event was a fracture that occurred during the revision procedure that required fixation with a trochanteric gripper and dall-miles cables.Again, the intraoperative findings and description were not provided.The third event would be the need to remove the trochanteric gripper and cables due to pain.Lastly, there was an apparent fracture of the revision restoration modular stem as exhibited on a single ap hip x-ray.Again, no details in the form of medical records were provided for that event.Hazards: there were two hazards noted, the first was the likely association of the high metal levels and a pseudo tumor that led to revision surgery and relation to the rejuvenate stem.The second was the fracture of the conical restoration modular stem.Conclusion of assessment: the patient had a tha with a rejuvenate stem.This resulted in high metal levels and a pseudo tumor that led to revision surgery.At the time of the revision a fracture occurred that required fixation with a trochanteric gripper and cables.The hardware became painful and was removed after healing of the fracture.The revision stem subsequently fractured and will be/was revised.-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 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 altr is considered to be under the scope of this recall.No further investigation is required.

• Brand Name: UNKNOWN REJUVENATE STEM SIZE 8
• 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: 11784085
• MDR Text Key: 249276603
• Report Number: 0002249697-2021-00802
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• 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: 05/31/2021
• 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
• Patient Age: 60 YR
• Patient Weight: 95