MAUDE Adverse Event Report: SYNTHES MONUMENT 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.007S

Device Problems Loose or Intermittent Connection (1371); Unintended Movement (3026)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient identifier, date of birth/age, and weight are unknown.Date of postoperative device movement/loosening is unknown.This report is for one (1) unknown radial head prosthesis stem.(other): without a valid part and lot number, the udi is not available.The original implant procedure was performed on an unknown date approximately six (6) to eight (8) months ago.No revision procedure has been scheduled at this time.The complainant part is not expected to be returned for manufacturer review/investigation.Unknown, as specific part and lot numbers for the complainant part were not provided.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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

It was reported that a patient underwent a radial head prosthesis implant procedure approximately six (6) to eight (8) months ago.Sometime postoperative, the radial head prosthesis stem loosened in the shaft of the proximal ulna.Subsequently, it was discovered that the stem had loosened as well.At this time, there is no revision date scheduled.This report is for one (1) unknown radial head prosthesis stem.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Unknown if explanted device is/not expected to be returned for manufacturer review/investigation.Device history records was conducted.The report indicates that the: dhr review for part# 04.402.007s lot# 7683416 release to warehouse date: 19nov2014 supplier: nemcomed, packaged by: synthes: (b)(4) expiration date: 10/31/2019 no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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

Update 2/24/16: the patient underwent a hardware removal on (b)(6) 2016.2016.Explanted hardware included one 22mm cobalt-chromium(cocr) radial head and one 7mm titanium(ti) straight radial stem, both fully intact.The procedure was completed successfully without incident and with the patient in stable condition.

Manufacturer Narrative

(b)(4).Updated from malfunction to serious injury.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.

Manufacturer Narrative

(b)(6).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: 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5450889
• MDR Text Key: 38675880
• Report Number: 2520274-2016-11183
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 04.402.007S
• Device Lot Number: 7683416
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention