MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 9MM TI STRAIGHT RADIAL STEM 30MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.009S

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Patient weight was not provided for reporting.Date of event is unknown.Device remained implanted at the time of reporting.Explant date is not applicable.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2016, patient was implanted with radial head prosthesis.Post-operative, on one year follow up, x- ray showed signs of loosening.During one and half year follow up, it was noted that the loosening became worse.Reportedly, patient is in pain.Device remains implanted and explant surgery has not been planned.This report is for one (1) 9 mm ti straight radial stem 30 mm-sterile.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Five x-ray pictures were received showing a loosen stem because of unknown reason as described in the event description.This complaint is confirmed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 9MM TI STRAIGHT RADIAL STEM 30MM-STERILE
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7641542
• MDR Text Key: 112453538
• Report Number: 8030965-2018-54656
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 07611819511071
• UDI-Public: (01)07611819511071
• Combination Product (y/n): N
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.402.009S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2018
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR