MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COCR MOD HD STD; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 110010243 ¿ g7 shell ¿ 6675521, 12-151311 ¿ echo stem ¿ 444760, 00785901100 ¿ distal centralizer ¿ 64381064, 30123604 ¿ g7 liner ¿ 64561334.Product has been received and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial hip procedure, the femoral head would not engage to the taper of the stem.A new head was used to complete the surgery.There is no reported harm or injury to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the event is confirmed.Visual inspection of the returned device identified micro cosmetic flaws.The inside taper has two areas on the chamfer that show micro burrs to the edge.The burrs begin at the lower edge and move up the chamfer, but do not extend down in to the taper.No sharp edge felt around taper chamfer and rough area did not snag or cut a glove.The dome surface has one small scuff on the top of the dome.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.A summary of the investigation was sent to the customer.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: COCR MOD HD STD
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9911624
• Report Number: 0001825034-2020-01405
• Device Sequence Number: 3387920
• Product Code: JDI
• UDI-Device Identifier: 00887868307959
• UDI-Public: (01)00887868307959
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K032396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-363662
• Device Lot Number: 434920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 05/06/2020
• 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: N/A
• Patient Sequence Number: 1