MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Model Number	09.402.022S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age, date of birth, gender, and weight not available for reporting.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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 or Problem Description
It was reported patient was implanted with the radial head prosthesis system on unknown date.On an unknown date patient reported pain.Patient was returned to surgery on (b)(6) 2018 where surgeon intended to remove both the radial head and radial stem.However, only the radial head was able to be removed.The radial stem could not be removed due to bony growth.Surgery was completed with no reported delay.Patient reported to be in stable condition.There is currently no plan to attempt to remove the radial stem.This report is for one (1) 22mm radial head standard height 12.5mm.This is report 1 of 2 for (b)(4).
Additional 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.A device history record (dhr) review was conducted: manufacturing location: supplier nemcomed.Packaged by: monument, manufacturing date: 12-sep-2013, expiration date: 31-aug-2018: part #: 09.402.022s, lot#: 7379068 (sterile) - 22mm cocr radial head standard height/12.5mm - sterile.Quantity 50.Component parts reviewed: part 21022 lot 5317556 and part 41060 lot 7264642 were and they meet specification.Certificate of compliance received from avalign (nemcomed) meet specification.Inspection sheet for incoming final inspection ns051180 rev: c met inspection acceptance criteria.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.A product investigation was conducted.The following investigation flow was performed: adverse event (no reported product problem).Visual inspection performed at customer quality (cq) was not able to confirm the condition of pain and stiffness, which does not agree with the reported complaint condition.The returned radial head shows wear consistent with implantation and explantation, but no damage that would inhibit function or cause pain or stiffness was observed.The returned implant was manufactured in september 2013.Based on the reported information and returned device, this complaint was not able to be confirmed.On 30 december 2016 synthes initiated a voluntary medical device removal (recall) of the depuy synthes radial head prosthesis system and appropriate actions have been taken to address the issue.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 or Problem Description
On an unknown postoperative date patient reported pain and stiffness.

• Brand Name: 22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE
• Common Device Name: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7463200
• Report Number: 2939274-2018-51933
• Device Sequence Number: 11014801
• Product Code: KWI
• UDI-Device Identifier: 10886982132598
• UDI-Public: (01)10886982132598
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K112030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2018

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: Health Professional
• Device Model Number: 09.402.022S
• Device Catalogue Number: 09.402.022S
• Device Lot Number: 7379068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 06/04/2018
• 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: Z-1124-2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention