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

Catalog Number SPT-080000S

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

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

Event Date 03/22/2016

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 revision, trunnionosis and corrosion is considered to be under the scope of this recall.No further investigation is required.Device not returned.

Event Description

Information received from broadspire: it was reported that the patient is asymptomatic.Update 28/july/2020 (b)(6): it was reported that the patient's left hip was revised due to trunnionosis at the head/ neck junction and corrosion at the head/ neck and stem/ neck junctions.Patient was revised to a restoration ha stem and ceramic head.Rep confirmed that the liner and shell were not revised.No further information will be released by the hospital or surgeon.

Event Description

Information received from broadspire: it was reported that the patient is asymptomatic.Update 28/july/2020 wg: it was reported that the patient's left hip was revised due to trunnionosis at the head/ neck junction and corrosion at the head/ neck and stem/ neck junctions.Patient was revised to a restoration ha stem and ceramic head.Rep confirmed that the liner and shell were not revised.No further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding corrosion 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.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-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 corrosion 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, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10436758
• MDR Text Key: 203841045
• Report Number: 0002249697-2020-01690
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: SPT-080000S
• Device Lot Number: MKL1RH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• 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
• Patient Age: 74 YR