MAUDE Adverse Event Report: ZIMMER BIOMET, INC.; PROSTHESIS, HIP

Catalog Number SEE H10 NARRATIVE

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

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date: left: (b)(6) 2008 - right: (b)(6) 2008.Concomitant products: x180311-bi-metric/x por nc 11x135-362280; x180310-bi-metric/x por nc 10x130-463480; 11-163690-32mm m2a hi carbon hd +6mm nk-985990; 11-163688-32mm m2a hi carbon hd std nk-544260; 10-111152-c2a-t m/h rad 2hl shl 41/52mm-949700; 10-111152-c2a-t m/h rad 2hl shl 41/52mm-919670.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 10193, 0001825034 - 2018 - 10191, 0001825034 - 2018 - 10192.Two device ids were provided by the customer/reporter; of these, only one was revised.It is unknown which exact side/device encountered this issue, it is one of the following: left side: item#: 15-105044, lot#: 473940, manufacture date: oct 1, 2007, sterile expiry date: oct 31, 2017, 510k: k003363, pro code: kwy, implant date: (b)(6) 2008.Or right side: item#: 15-105044, lot#: 090660, manufacture date: dec 1, 2007, sterile expiry date: dec 31, 2017, 510k: k003363, pro code: kwy, implant date: (b)(6) 2008.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device location is unknown.

Event Description

It was reported patient underwent a hip revision due to unknown reasons at an unknown amount of time post initial 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: left side c2a shell updated: manufacturing date: sep 30, 2007.Expiration date: sep 30, 2017.D10: right side c2a shell corrected: lot 949670 updated: manufacturing date: sep 30, 2007.Expiration date: sep 30, 2017.Medical records/radiographs were provided and reviewed by a health care professional.A review of the initial op records indicated no complications.A review of the device history records identified no deviations or anomalies during manufacturing.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 Description

No additional information on the reported event.

• Type of Device: 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: 12797159
• MDR Text Key: 280683911
• Report Number: 0001825034-2021-03116
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

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 Catalogue Number: SEE H10 NARRATIVE
• Device Lot Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 11/17/2021
• 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: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White