MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign: country: (b)(6).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.
Event or Problem Description
It was reported during the inspection of the loaner kit in the (b)(6) warehouse, it has been detected that the piece has been received with packaging opened.No patient involved.No surgery occurred.No additional information.
Event or Problem Description
Upon reassessment of the reported event, sterility has not been compromised and determined to be not reportable.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
Reported event was confirmed by review of photos.Visual evaluation of the provided photo(s) found the shrink wrap has been removed and the end flap of the carton has shifted.As this end of the carton is not meant to be opened, it can be reasonably concluded that the product has not been opened.There is not evidence of breach of the tamper seal as shown in the photo provided.However, a full view of the tamper seal is not available.Device history record (dhr) was reviewed and no discrepancies were found.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 during redistribution of the product.Upon reassessment of the reported event, it has been determined that the device sterility has not been compromised.The initial report was forwarded in error and should be voided.

• Brand Name: FEMORAL HEAD
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11672313
• Report Number: 0002648920-2021-00081
• Device Sequence Number: 19622150
• Product Code: LPH
• UDI-Device Identifier: 00889024144620
• UDI-Public: (01)00889024144620(17)300731(10)64770374
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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: 00801802802
• Device Lot Number: 64770374
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/17/2021
• 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