MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM COCR MOD HD -6MM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Fall (1848); Ambulation or Postural Difficulties (2544)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 51-107110; tprlc 133 mp type1 pps ho 11.0; lot number 3658289.Report source: foreign: canada.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2023 -00820.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.Device location is unknown.
Event or Problem Description
It was reported pt underwent a revision procedure approximately 5 years post-implantation due to a fall that resulted in the stem moving because of the fall.In surgical notes, surgeon noted that the stem and the cup were not loose, but since the stem had moved from original x-rays he decided to change stem to an arcos.The surgeon noted all implants were in good conditions.No problem occurred during revision of stem.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
Upon reassessment of the reported event, the head 11-363660 was determined to be not reportable.The initial report 0001825034 - 2023 - 00819 was forwarded in error and should be voided.The following sections were updated updated:.
Event or Problem Description
Upon reassessment of the reported event, the head 11-363660 was determined to be not reportable.The initial report 0001825034 - 2023 - 00819 was forwarded in error and should be voided.

• Brand Name: 36MM COCR MOD HD -6MM
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16742088
• Report Number: 0001825034-2023-00819
• Device Sequence Number: 15087907
• Product Code: JDI
• UDI-Device Identifier: 00880304210509
• UDI-Public: (01)00880304210509(17)260401(10)528560
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K032396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• 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): 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/01/2026
• Device Model Number: N/A
• Device Catalogue Number: 11-363660
• Device Lot Number: 528560
• Was Device Available for Evaluation?: No
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female