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

Model Number	RHA-H4
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Remains implanted.
Event or Problem 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.
Additional 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 or Problem 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)
• Common Device Name: ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7493790
• Report Number: 0008031020-2018-00349
• Device Sequence Number: 13872507
• Product Code: KWI
• UDI-Device Identifier: 00886385024684
• UDI-Public: (01)00886385024684
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K002644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 98