MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC STEM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01256, 0001825034-2020-01254, 0001825034-2020-01252, 0001825034-2020-01257, 0001825034-2020-01259.
Event or Problem Description
It was reported that during investigation of stock products, debris was notified within the sterile packaging.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated against the reported event.Part # 51-103140 from lot 3711444 visual inspection confirmed black debris within the sterile packaging.The blister seal remains intact.No significant damage was observed on the outer packaging.Dhr was reviewed and no discrepancies were found.Investigation has concluded that the condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event is likely due to transit damage causing porous coating to shed from the implant.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.

• Brand Name: TAPERLOC STEM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9866364
• Report Number: 0001825034-2020-01258
• Device Sequence Number: 13584442
• Product Code: KWA
• UDI-Device Identifier: 00880304491816
• UDI-Public: 00880304491816
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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: 01/21/2026
• Device Model Number: N/A
• Device Catalogue Number: 51-103140
• Device Lot Number: 3711444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 06/25/2020
• 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