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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: catalog#: 103534 ti low profile screw 6.5x35mm ia6.5x35mm lot#: 624060.Catalog#: 13-104156 m/h 3hole rlc shl nrs 56mm/l24 lot#: 215780.Catalog#: 103532 bm acet lp dome scw ti s/tap d ia6.5x25mm lot#: 120880.Catalog#: 135300 acetabular apex plug lot#: 033870.Catalog#: 105994 rnglc lnr 26mm hwall 24 lot#: 464560.Catalog#: 51-104110 tprlc 133 t1 pps ho 11x142mm 2mm t1 lot#: 3727019.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: 0001825034-2021-01594, 0001825034-2021-01600, 0001825034-2021-01601, 0001825034-2021-01602, 0001825034-2021-01605, 0001825034-2021-01608.

Event Description

It was reported the patient is experiencing a feeling like fire is running down the leg and hip, numbness, pain, feels like a tennis ball is in the butt cheek, the patient cannot ride in a vehicle for long periods, and the patient has difficulty lifting his leg approximately 4 years and 9 months post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: -catalog#: 13-104156 m/h 3hole rlc shl nrs 56mm/l24 lot#: 215870 -catalog#: 103534 ti low profile screw 6.5x35mm ia6.5x35mm lot#: 642060 -catalog#: 103532 bm acet lp dome scw ti s/tap d ia6.5x25mm lot#: 120880 -catalog#: 135300 acetabular apex plug lot#: 033870 -catalog#: xl-105994 arcomxl 36mm rlc lnr mrom sz24 lot#: 464560 -catalog#: 51-104110 tprlc 133 t1 pps ho 11x142mm 2mm t1 lot#: 3727019 the following sections were updated/corrected updated: b4, b5, d4, d10, g3, g6, h2, h3, h4, 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 Description

No further event information available at the time of this report.

• Brand Name: 36MM COCR MOD HD STD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11884024
• MDR Text Key: 252611771
• Report Number: 0001825034-2021-01603
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K032396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-363662
• Device Lot Number: 351930
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Patient Outcome(s): Other