MAUDE Adverse Event Report: STRYKER GMBH RADIAL STEM IMPLANT #2 (STERILE PACKED); ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Model Number RHA-S2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 01/14/2017

Event Type  Injury  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

A patient reported that five months post left radial head arthroplasty for comminuted radial head fracture they developed increasing pain and loss range of motion.Surgeons found patient had a grossly radial head implant when weight bearing of the renal stem.Patient had close to zero pronation and supination and lacking 20 degrees extension.X-rays and revision surgery concluded these findings.Revision surgery was needed 5 months after initial surgery.

Manufacturer Narrative

Please note correction to d4 lot number.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿strenuous loading, excessive mobility, and articular instability all may lead to accelerated wear and eventual failure by loosening, fracture, or dislocation of the device.Patients should be made aware of the increased potential for device failure if excessive demands are made upon it.Adverse effects may necessitate reoperation, revision, or fusion of the involved joint.While the expected life of joint replacement components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential restoration of mobility or reduction of pain.However, due to the many biological, mechanical and physiochemical factors which affect these devices, the components cannot be expected to withstand the activity level and loads of normal healthy bone for an unlimited period of time.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

A patient reported that five months post left radial head arthroplasty for comminuted radial head fracture they developed increasing pain and loss range of motion.Surgeons found patient had a grossly radial head implant when weight bearing of the renal stem.Patient had close to zero pronation and supination and lacking 20 degrees extension.X-rays and revision surgery concluded these findings.Revision surgery was needed 5 months after initial surgery.

• Brand Name: RADIAL STEM IMPLANT #2 (STERILE PACKED)
• Type of Device: ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12249540
• MDR Text Key: 264260846
• Report Number: 0008031020-2021-00328
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00886385024721
• UDI-Public: 00886385024721
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

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: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: RHA-S2
• Device Catalogue Number: RHAS2
• Device Lot Number: 24994601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2015
• 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): Required Intervention