MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH REJUVENATE STRGHT PRFIT TMZF 132 MONO STEM SIZE 5; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number SPT-053200S

Device Problem Degraded (1153)

Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)

Event Date 02/03/2016

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

Information received from (b)(6): it was reported that the patient had a revision surgery.Implant sheet and operative notes from legal department identify the following: revision date (b)(6) 2016, operative side left, alleged persistent pain, alleged acetabular component loosening, alleged elevated cobalt and chromium levels (levels not reported), alleged black flaky residue consistent with corrosion, alleged failure of the cup to osseointegrate.Patient factor: hyperlipidimia.

• Brand Name: REJUVENATE STRGHT PRFIT TMZF 132 MONO STEM SIZE 5
• 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: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7035027
• MDR Text Key: 92153468
• Report Number: 0002249697-2017-03372
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2017

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: 10/12/2014
• Device Catalogue Number: SPT-053200S
• Device Lot Number: MHM030-1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR