MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COF 2 ECCENTRIC 4M HD 22X44MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	71259622
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/22/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported revision surgery was performed to add a glenoid.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Our clinical investigation noted that based on the provided clinical information, the patient impact beyond the minimal surgical delay and the revision surgery itself cannot be concluded.The surgeon does not anticipate any further medical or surgical interventions due to the reported event.No further medical assessment can be rendered at this time.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed parts revealed no additional complaints for this failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
Event or Problem Description
Additional information received indicates the surgeon wanted to change the head from a lateralized offset to an eccentric head.However, during the procedure the heads were loose so the surgeon impacted the original head back on.

• Brand Name: COF 2 ECCENTRIC 4M HD 22X44MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6868947
• Report Number: 1020279-2017-00749
• Device Sequence Number: 13813840
• Product Code: KWS
• UDI-Device Identifier: 03596010464491
• UDI-Public: 03596010464491
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K003566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/24/2018

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 Expiration Date: 12/10/2022
• Device Catalogue Number: 71259622
• Device Lot Number: 09DM03061B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 08/23/2017; 08/23/2017; 08/23/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 03/12/2018; 04/04/2018; 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention