MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COCR HEAD 48MM/18.00MM STERILE; PROSTHESIS,SHOULDER,NONCONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 5331-48/18

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Not Applicable (3189)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient information is unknown.(b)(4).Gtin unavailable, product made prior to gtin compliance date.Udi not available and lot number unknown.Implant date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a surgeon planned to convert an epoca hemiarthroplasty prosthesis to a reverse total shoulder on (b)(6) 2018 due to a irreparable rotator cuff tear.All devices were removed fully intact.The epoca revision instrument set was sent in and the hardware was removed uneventfully on (b)(6) 2018.(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.Event : it was initially reported on mwr-(b)(4) that the event occurred on (b)(6) 2018; however, it is unknown when the rotator cuff tore.Therefore, there is no event date.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.Device is a single use device but was not reprocessed or reused.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: COCR HEAD 48MM/18.00MM STERILE
• Type of Device: PROSTHESIS,SHOULDER,NONCONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7341529
• MDR Text Key: 102497460
• Report Number: 2939274-2018-51068
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K072578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 5331-48/18
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 04/04/2018; 04/13/2018
• Supplement Dates FDA Received: 04/16/2018; 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention