MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. G7 OSSEOTI MULTIHOLE 52MM E; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: japan.Visual evaluation of the returned product found the sterile barrier (blister) exhibits damage visually consistent with thermal damage.Sterility has been breached.This complaint has been confirmed by review of the returned product.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.The condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the packaging operator not following the work instructions provided.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
It was reported that the shape of the plastic inner tray was deformed.It looked as if it had been melted by heat.This implant was used however the inner tray can be returned.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: g3; h2; h3; h10.Visual evaluation of the returned product found the sterile barrier (blister) exhibits damage visually consistent with thermal damage.Review of the internal evaluation and tensile test results by the manufacturing site found the blister deformity does not affect the sterility.Review of complaint history found no additional related issues for the reported product.The condition of the device when it left zimmer biomet is considered non-conforming to specification.The root cause of the reported event is the packaging operator not following the work instructions provided.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: G7 OSSEOTI MULTIHOLE 52MM E
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16942224
• Report Number: 3007963827-2023-00130
• Device Sequence Number: 20561824
• Product Code: LPH
• UDI-Device Identifier: 00887868356025
• UDI-Public: (01)00887868356025(17)320713(10)65451219
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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: 110010264
• Device Lot Number: 65451219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Unknown