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

Model Number N/A

Device Problem Migration (4003)

Patient Problems Fall (1848); Ambulation Difficulties (2544)

Event Date 06/07/2021

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 313302557
• Report Number: 0001825034-2023-00819
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304210509
• UDI-Public: (01)00880304210509(17)260401(10)528560
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K032396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• 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
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female