MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL¿¢ ACETABULAR REVISION SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: event occurred in (b)(6).
Event or Problem Description
It was reported that when the device was being opened, the sterile packaging from not intact and appeared to be crushed.The surgeon did not use the implant due to possible sterility breach.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product identified that the outer carton and sterile cavities had been opened; no damage was found on the outer carton.The outer sterile cavity and tyvek lids were not returned, and the inner sterile cavity was damaged.Review of the device history records identified no related deviations or anomalies during manufacturing.The product was likely conforming when it left zimmer biomet control.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TRABECULAR METAL¿¢ ACETABULAR REVISION SHELL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 9545089
• Report Number: 3005751028-2020-00001
• Device Sequence Number: 2334267
• Product Code: LPH
• UDI-Device Identifier: 00889024310872
• UDI-Public: (01)00889024310872
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K003181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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 Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00700005620
• Device Lot Number: 63959508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1