MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM COCR MOD HD STD; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: item# 12-151413 item name: echo hip fx lat femoral 13mm lot# 623710; item# 110010245 item name: g7 osseoti 4 hole shell 54mm f lot# 6833713; item# 30123606 item name: g7 vit e high wall lnr 36mm f lot# 64797292.Product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported during an initial hip arthroplasty when the surgeon impacted femoral head onto femoral stem, the implant did not engage taper.A new head was opened and utilized and new head engaged onto same stem.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.One 36mm cocr mod hd std item# 11-363662 lot# 706880 was returned and evaluated.Upon visual inspection there is no visible damage to the device either in the taper or on the outside diameter.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.Radiographs were received and identified that images are of left hip preplanning image and one of immediate post implant.As the complaint is for issues with head and taper during implantation, neither of these images would assist in the investigation, therefor images will not be submitted for review.A definitive root cause cannot be determined.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.

• Brand Name: 36MM COCR MOD HD STD
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11197325
• Report Number: 0001825034-2021-00115
• Device Sequence Number: 13622520
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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: 706880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 04/15/2021
• 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