MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NTINUUM TM SHELL CLUST 56 KK; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised due to pain and poor cup position approximately 2 years post implantation.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
(b)(4).Catalog number:00-8757-056-01, lot number:77010387, brand name: continuum tm shell.Catalog number:00-8852-012-36, lot number: 64802356, brand name: vit e liner elevated.Catalog number:00-7848-022-00, lot number:64746102, brand name: kinectiv modular.Catalog number:00-6250-065-30, lot number:j6793110, brand name: bone screw.Catalog number:00-6250-065-36, lot number:j6828155, brand name: bone screw.Catalog number: 00-7713-011-00, lot number:64816986, brand name: m/l taper stem.Catalog number: 00-8775-036-02, lot number:3043607, brand name: biolox delta head.Multiple reports were submitted along with this report: 0001822565-2022-01024, 0001822565-2022-01025.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: slight decreased lateral inclination of the left acetabular cup.Reported event was confirmed by review of x-rays provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Root cause could not 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.

• Brand Name: NTINUUM TM SHELL CLUST 56 KK
• 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: 14135294
• Report Number: 0001822565-2022-01023
• Device Sequence Number: 20391261
• Product Code: LPH
• UDI-Device Identifier: 00889024151437
• UDI-Public: (01)00889024151437(17)310530(10)77010387
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00875705601
• Device Lot Number: 77010387
• 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: 03/23/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female