MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COCR FEM HD 44MM TYPE 1 +12MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet 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 when opening the implants packaging, they noticed the inner packaging was compromised.No patient was harmed.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.The following sections were updated/corrected updated: g3; h2; h3; h4; h6 visual examination of the returned product/provided pictures found the sterile blister was damaged.No damage to sterile pouch.Sterility has not been compromised.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for this item and the reported part and lot combination.The condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can be attributed to transit damage.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.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 information on the reported event.

• Brand Name: COCR FEM HD 44MM TYPE 1 +12MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11332547
• Report Number: 0001825034-2021-00500
• Device Sequence Number: 19771446
• Product Code: PBI
• UDI-Device Identifier: 00880304527850
• UDI-Public: (01)00880304527850(10)3109619(17)230905
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• 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): 05/11/2021

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 Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 010001038
• Device Lot Number: 3109619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 05/11/2021
• 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: NI
• Patient Sequence Number: 1
• Patient Age: 41 YR