MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM COCR MOD HD -3MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Unequal Limb Length (4534)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog#: 51-104140 tprlc 133 t1 pps ho 14x148mm lot#: 6554836.Catalog#: 110010247 g7 osseoti 4 hole shell 58mm g lot#: 6627153.Catalog#: 010000859 g7 neutral e1 liner 36mm g lot#: 6560624.Catalog#: 010001005 g7 screw 6.5mm x 70mm lot#: 3299353.Catalog#: 00625006550 bone scr 6.5x50 self-tap lot#: 64187043.Catalog#: 31-323215 3.2mmx15mm rnglc+ acet drl bit lot#: 338820.Catalog#: 31-323230 3.2mmx30mm rnglc+ acet drl bit lot#: 806750.Catalog#: 31-323250 3.2mmx50mm rnglc+ acet drl bit lot#: 628120.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00343, 0001825034-2022-00344, 0001825034-2022-00346.
Event or Problem Description
It was reported that the patient underwent a left hip arthroplasty.Subsequently, patient alleges that the representative provided the wrong size hip to be implanted.Patients one leg is longer than the other leaving the patient unable to walk properly or engage in most activities without pain.No revision has been reported at this time.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h2, h3, h6, h10 reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - head.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient does report some pain from the back going down the right side, left side is numb along the lateral side, some focal disk bulges noted, (pre-existing) foot drop on the left side, half inch leg length difference noted.During the initial procedure, the femur was broached to accept a 15, but upon placing the final implant, did not quite make it all the way down.The additional information does not change the outcome of the previous investigation.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that a patient had a motor vehicle accident resulting in multiple fractures and a left hip open reduction internal fixation approximately 21 years ago.Over time, the patient developed posttraumatic avascular necrosis of the hip and underwent a staged procedure with hardware removal and antibiotic cement bead placement in stage one then and a left total hip arthroplasty one week later.During the initial procedure, the femur was broached to accept a 15, but upon placing the final implant, did not quite make it all the way down.The surgeon was satisfied with the result and closed the patient.Following the procedure, the patient was left with a half inch leg length discrepancy and reported ongoing pain and difficulties.Physical therapy has been exhausted and discontinued to lack of progress, physical deconditioning, and injury prevention due to patient expectations.No further event information available at the time of this report.

• Brand Name: 36MM COCR MOD HD -3MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13523094
• Report Number: 0001825034-2022-00345
• Device Sequence Number: 4158808
• Product Code: JDI
• UDI-Device Identifier: 00887868307942
• UDI-Public: (01)00887868307942(17)290508(10)875710
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K032396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/20/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-363661
• Device Lot Number: 875710
• 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: 01/24/2022
• Supplement Date Received by Manufacturer: 03/14/2022; 09/26/2022; 10/20/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/15/2022; 10/17/2022; 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White