MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ E HI 60MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi: (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product identified that the carton and sterile packaging was damaged.The sterility of the product is compromised.Device history record (dhr) was reviewed and identified no deviations or anomalies during manufacturing related to the reported event.The likely condition of the product when it left zimmer biomet control was conforming to specifications.The root cause is attributed to transit damage.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
Device was returned with packaging damage and the sterility barrier potentially compromised.

• Brand Name: ARCOS CON SZ E HI 60MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10417133
• Report Number: 0001825034-2020-03207
• Device Sequence Number: 14064730
• Product Code: KWA
• UDI-Device Identifier: 00880304480551
• UDI-Public: (01)00880304480551
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

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 Model Number: N/A
• Device Catalogue Number: 11-301315
• Device Lot Number: 714460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 08/17/2020
• 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