MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number SPT-080000S

Device Problem Device-Device Incompatibility (2919)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Metal Related Pathology (4530)

Event Date 11/10/2020

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.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 corrosion is considered to be under the scope of this recall.No further investigation is required.

Event Description

It was reported that following a revision of rejuvenate femoral stem for fibrous, pseudo-tumor it was discovered that the patient exhibited evidence of metallosis and abductor deficiencies.

Event Description

It was reported that following a revision of rejuvenate femoral stem for fibrous, pseudo-tumor it was discovered that the patient exhibited evidence of metallosis and abductor deficiencies.

Manufacturer Narrative

Correction: d4 lot updated from minrdn to mjnrdn.Reported event: an event regarding altr and metallosis involving a rejuvenate modular device was reported.The event was not confirmed.Method & results: device evaluation and results:visual inspection: the device was not returned however photographs were provided for review.The image shows significant amount of blood on the device there is evidence of bone attached to the device.Material analysis, 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.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: 4 undated, unlabelled color photos of explanted intact rejuvenate stem and attached modular neck with some boney ongrowth proximal stem with manufacturer's marking on stem visible - no gross pathology noted.Undated x-ray: ap left hip with uncemented, modular stem tha, reduced, nominal position with lateral femoral cortex defects and marked periarticular radio- dense particulate debris.No clinical or pmh, no patient demographics, no operative reports, no dated serial imaging studies.No lab or surgical pathology reports, no examination of explanted components.Based upon the information available for review, neither confirmation of the event description nor preparation of a medical report is possible for this case.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 and metallosis is considered not to be under the scope of this recall.No further investigation is required.

• Brand Name: REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8
• 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
• MDR Report Key: 10941122
• MDR Text Key: 219363475
• Report Number: 0002249697-2020-02578
• 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: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: SPT-080000S
• Device Lot Number: MJNRDN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• 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