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); Pain (1994); Metal Related Pathology (4530)

Event Date 04/01/2015

Event Type  Injury  

Manufacturer Narrative

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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported 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 pain and elevated levels is considered to be under the scope of this recall.No further investigation is required.Not returned to the manufacturer.

Event Description

Information received from broadspire: it was reported that the patient has pain, metallosis - elevated levels of chromium & cobalt, clicking noise.Additional information received from legal: plaintiff alleges the left rejuvenate hip implanted on or about (b)(6) 2010 failed causing pain and elevated metal ion levels.Plaintiff has not yet scheduled revision surgery.As reported by rep: "revision of left total hip.Patient had rejuvenate stem removed.Patient cobalt level was 18." spoke to rep.A rejuvenate modular stem and neck, and cocr head were revised.Rep confirmed that no further information will be released by the hospital or surgeon.

Event Description

Information received from broadspire: it was reported that the patient has pain, metallosis - elevated levels of chromium & cobalt , clicking noise.Additional information received from legal: plaintiff alleges the left rejuvenate hip implanted on or about (b)(6) 2010 failed causing pain and elevated metal ion levels.Plaintiff has not yet scheduled revision surgery.As reported by rep: "revision of left total hip.Patient had rejuvenate stem removed.Patient cobalt level was 18." spoke to rep.A rejuvenate modular stem and neck, and cocr head were revised.Rep confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding wear(metallosis) and abnormal ion levels 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 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 wear (metallosis) and abnormal ion levels is considered 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13308180
• MDR Text Key: 288700457
• Report Number: 0002249697-2022-00110
• 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,Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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-080000S
• Device Lot Number: MHTMHP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/29/2021
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 01/27/2022
• Supplement Dates FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2010
• 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: 70 YR