MAUDE Adverse Event Report: STRYKER GMBH RADIAL HEAD IMPLANT #3 (STERILE PACKED); PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Catalog Number	RHAH3
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: implanted in patient.
Event or Problem Description
It was reported that the patient complained of pain of the left radius after implantation in (b)(6) 2017.A ct scan on (b)(6) 2019 showed loosening of the radial head.Possible cause or contributor for loosening was not reported to the rep.Surgeon has not yet reported any plan to revise the patient.Per the operative report, as part of the ct scan, soft tissues appeared within normal limits and the remaining bony structures were unremarkable, therefore no serious injury occurred.
Additional Manufacturer Narrative
The reported event could be confirmed, since x-rays confirming the failure mode were provided.More detailed information about the patient's data and patient's activity level is needed in order to determine the root cause of the complaint.However, based on the past complaint history a possible cause for the implant loosening is, but is not limited to the application of inappropriate loads on the device could be one of the most probable reasons of the loosening.As a reminder, the ifu clearly states: "warnings (see the patient counseling information section also) 1.Strenuous loading, excessive mobility, and articular instability all may lead to accelerated wear and eventual failure by loosening, fracture, or dislocation of the device." a review of the device history was not possible because the lot number communicated was wrong.The reported lot number (10192-l06) does not yield any results on our lot number databases.We conclude that the lot provided is wrong.No corrective actions are required at this time.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
It was reported that the patient complained of pain of the left radius after implantation in (b)(6) 2017.A ct scan on (b)(6), 2019 showed loosening of the radial head.Possible cause or contributor for loosening was not reported to the rep.Surgeon has not yet reported any plan to revise the patient.

• Brand Name: RADIAL HEAD IMPLANT #3 (STERILE PACKED)
• Common Device Name: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8441694
• Report Number: 0008031020-2019-00296
• Device Sequence Number: 11516559
• Product Code: KWI
• UDI-Device Identifier: 00886385024677
• UDI-Public: 00886385024677
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: RHAH3
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 8031020-10/24/2017-002-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR