MAUDE Adverse Event Report: STRYKER GMBH RADIAL HEAD IMPLANT #4 (STERILE PACKED); ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Model Number RHA-H4

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 03/30/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Remains implanted.

Event Description

Patient called and stated that he had a elbow replacement done on (b)(6) 2017.On or about (b)(6) 2018 he started experiencing pain in his elbow.He went to his doctor and had x-rays and was told that the implant had loosened and needs to be replaced.Patient is also inquiring about recall.

Manufacturer Narrative

The reported event that radial head implant #4 (sterile packed) was alleged of 'implant - loose' could not be confirmed, since the device was not returned for evaluation and no other evidences (no x-rays) were provided.As there was no response from the patient despite multiple attempts.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.A review of the device history for the reported lot did not indicate any abnormalities.Nevertheless an (b)(4) was already initiated to address this problem.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

Patient called and stated that he had a elbow replacement done on (b)(6) 2017.On or about (b)(6) 2018 he started experiencing pain in his elbow.He went to his doctor and had x-rays and was told that the implant had loosened and needs to be replaced.Patient is also inquiring about recall.

• Brand Name: RADIAL HEAD IMPLANT #4 (STERILE PACKED)
• Type of Device: ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7493790
• MDR Text Key: 107570846
• Report Number: 0008031020-2018-00349
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00886385024684
• UDI-Public: (01)00886385024684
• Combination Product (y/n): N
• PMA/PMN Number: K002644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: RHA-H4
• Device Catalogue Number: RHAH4
• Device Lot Number: 10198L05
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 98