MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM TI STRAIGHT RADIAL STEM 30MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.009S

Device Problem Device Slipped (1584)

Patient Problems Arthritis (1723); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - radial head prosthesis/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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 Description

It was reported that on or about (b)(6) 2020, the patient underwent a revision surgery consisted of left elbow explantation of the radial head implant, left elbow radial capsulectomy and contracture release with extensive synovectomy and left wrist radiocarpal and midcarpal arthroscopies with joint debridement.It was noted that the radial head implant was quite loose and easily came out and further noted a brownish synovial change that appeared to be a metallic-like debris.Once the implant was removed, a capsulectomy and synovectomy were performed to remove the damaged tissue including loose pieces of cartilaginous tissue in the elbow joint.On or about (b)(6) 2015 the plaintiff fell and fractured his left elbow which has resulted in a comminuted fracture to the radial head.On or about (b)(6) 2015, the patient was implanted with a depuy synthes radial head prosthesis system and a left radial head arthroplasty was performed.Postoperatively, the patient regained much of his motion and function.On or about (b)(6) 2020 the plaintiff developed severe pain in his elbow which was determined to have been caused by the defective depuy synthes radial head prosthesis system.The pain had progressed in intensity and involved not just the elbow but the whole forearm and was having difficulty with grasping activities wherein the pain scale was 2 of 10 when at rest and 8 out of 10 when in use.The plaintiff was diagnosed with loosening of his depuy synthes radial head prosthesis system which caused metallosis, left elbow post-traumatic arthritis, left elbow post-traumatic contracture, left forearm/wrist essex-lapresi injury and left ulnar-sided wrist pain with tfcc insufficiency.This complaint involves 2 devices only.This report is for (1) unk - radial head prosthesis.This report is 2 of 2 (b)(4).

Manufacturer Narrative

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

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.H10: additional narrative: d10, h7, h9 h3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.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

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.

Manufacturer Narrative

H6: a device history record (dhr) review was conducted: manufacturing location: supplier - avalign nemcomed / inspected, packaged and released by: monument.Manufacturing date: 24-oct-2014.Expiration date: 30-sep-2019.Part number: 04.402.009s, 9mm ti straight radial stem 30mm ¿ sterile.Lot number: 7654217 (sterile).Lot quantity: 59.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: 21014, tialnbri16.00.Lot number: 7557656.Lot quantity: 3,059 lbs.Certified test reports were reviewed and determined to be conforming.Lot summary report dated 12-dec-2013 met all inspection acceptance criteria.Raw material receiving/putaway checklist 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.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

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.

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 history lot - manufacturing location: supplier - avalign nemcomed / inspected, packaged and released by: monument manufacturing date: 24-oct-2014.Expiration date: 30-sep-2019.Part number: 04.402.009s, 9mm ti straight radial stem 30mm ¿ sterile.Lot number: 7654217 (sterile).Lot quantity: 59.Work order traveler met all inspection acceptance criteria.Certificate of compliance received from alalign dated 29-sep-2014 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, ns050779 rev b met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev a was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 10698 supplied by sterigenics was reviewed and determined to be conforming.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: certified test report supplied by perryman company dated (b)(6) 2013 and inspection certificate supplied to perryman by vsmpo were reviewed and determined to be conforming.Lot summary report dated (b)(6) 2013 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review - 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.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): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11041019
• MDR Text Key: 222625971
• Report Number: 2939274-2020-05656
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 04.402.009S
• Device Lot Number: 7654217
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: UNK - RADIAL HEAD PROSTHESIS
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 122