MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7MM TI CURVED RADIAL STEM 42MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Model Number	04.402.027S
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes legal employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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 that on (b)(6) 2017, the patient underwent removal of a failed radial head implant due to severe pain and the loosening of the implant.The cocr radial head and titanium radial stem were removed.Procedure outcome was successful.Patient status is stable.The patient injured their left elbow on (b)(6) 2014 and went to the hospital on (b)(6) 2019 where x-rays were taken.On (b)(6) 2014, the patient had an open reduction internal fixation with the cocr radial head and titanium radial stem.X-rays of the patient¿s left elbow taken on (b)(6) 2014, showed good alignment of the radial head replacement.The coronoid fracture looked like it was healing nicely.X-rays taken on (b)(6) 2014, showed continuing good alignment of the radial head replacement.The fracture was well reduced.Patient was advised they could wean of their brace.On (b)(6) 2014, the patient complained of pain.It was also noted that the fracture was healed.Patient was still experiencing soreness on (b)(6) 2014.On (b)(6) 2017, the patient complained of increased pain in the left elbow over the last two (2) months or so.The patient¿s left elbow has some tenderness laterally.Three views of the patients left elbow showed significant loosening of the radial head implant with osteolysis around the stem.This report is for a 7 mm titanium (ti) curved radial stem.This is report 2 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.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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A device history record (dhr) review was conducted: manufacturing location: supplier - avalign nemcomed / inspected, packaged and released by: monument release to warehouse date: 28-mar-2013 expiration date: 28-feb-2018 part number: 04.402.027s, 7mm ti curved radial stem 42mm ¿ sterile lot number: 7012312 (sterile) lot quantity: 48 work order traveler met all inspection acceptance criteria.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 21069, tialnbri18.00 lot number: 5490857 lot quantity: 618 lbs.Product traveler met all inspection acceptance criteria.This lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release of the product that would contribute to this complaint condition.E3: reporter is attorney.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 CURVED RADIAL STEM 42MM-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: 8901687
• Report Number: 2939274-2019-59856
• Device Sequence Number: 243133
• Product Code: KWI
• UDI-Device Identifier: 10886982128096
• UDI-Public: (01)10886982128096
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K112030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2019

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: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 04.402.027S
• Device Catalogue Number: 04.402.027S
• Device Lot Number: 7012312
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 09/03/2019; 09/16/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/16/2019; 09/17/2019
• 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