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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 04/25/2011

Event Type  Injury  

Event Description

It was reported by patient, she had a left tha on (b)(6) 2011.Patient started to experience discomfort, pain and mobility issues right after her surgery.Patient received a recall letter from her surgeon in (b)(6) 2012.Patient was told by her surgeon she did not need to be revised at that time.Patient is still experiencing discomfort, pain and mobility issues.She sought another surgeon that's recommending revision.Patient would like assistance with her revision surgery.

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant 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.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 pain is considered to be under the scope of this recall.No further investigation is required.

Manufacturer Narrative

Reported event: an event regarding pain and elevated metal ions involving a rejuvenate modular device was reported.The event was not 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.- clinical review - medical records are provided to review and stated that - it is confirmed that the patient had a tha performed on (b)(6) 2011 and that she had chronic pain thereafter.Multiple investigations were undertaken as to the cause of this pain with out any definitive cause being established.In (b)(6) of 2013 she was found to have an elevation of both her serum chromium and cobalt levels but both were below the threshold indicative of the need for revision.The root cause for the patients chronic pain and sub threshold serum ion levels cannot be established from this limited documentation.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 exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported by patient, she had a left tha on (b)(6), 2011.Patient started to experience discomfort, pain and mobility issues right after her surgery.Patient received a recall letter from her surgeon in (b)(6) 2012.Patient was told by her surgeon she did not need to be revised at that time.Patient is still experiencing discomfort, pain and mobility issues.She sought another surgeon that's recommending revision.Patient would like assistance with her revision surgery.

• 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: 13666141
• MDR Text Key: 286560124
• Report Number: 0002249697-2022-00330
• 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: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: SPT-080000S
• Device Lot Number: MJHNTE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2010
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 70 KG