MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CUP; PROTHESIS, HIPS

Model Number N/A

Device Problems Naturally Worn (2988); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Fall (1848); Failure of Implant (1924); Insufficient Information (4580)

Event Date 02/03/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a left hip arthroplasty on an unknown date.Subsequently, the patient is being considered for a pmi product for an unknown reason.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

(b)(4).G2: foreign: south africa.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: a2, a3, a4, b3, b5, b7, g3, g6, h2, h6 no product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.Medical records were not provided.A definitive root cause cannot be determined.Unable to confirm complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the patient was born with hip dysplasia.The patients cup started to wear and was revised.The patient fell one year post implantation and it was found that the patient's cup was loose.It was recommended the patient wait for a custom implant.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.D10: 010001003 g7 screw 6.5mm x 50mm 6468223.010001000 g7 screw 6.5mm x 35mm 7073501.010000998 g7 screw 6.5mm x 25mm 6847824.11-301241 arcos cal sz a std +20 60mm 768840.00-2232-001-18 1.8mm stainless steel cable 65223148.00-2232-001-18 1.8mm stainless steel cable 65202341.00-4894-054-10 acet augm size 54.10mm thick 64803382.00-4199-001-38 acet restrictor 38mm dia 64583137.11-300615 arcos 15x200mm prx tpr dist 363960.110024465 g7 dual mobility liner 46mm g 357930.Ep-200152 act artic e1 hip brg 28x46mm 348730.650-1067 cer option type 1 tpr sleve +3 3087988.650-1055 cer bioloxd option hd 28mm 3087109.281001100 ball nose guide wire 100cm 165570.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02828; 0001825034 - 2023 - 02829; 0001825034 - 2023 - 02830.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: impressions: progressive osteolysis along both the femoral and acetabular implants of the left hip arthroplasty as noted with loosening and vertical malrotation of the acetabular implant.A definitive root cause cannot be determined.The event is confirmed via xray.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information to report at this time.

• Brand Name: UNKNOWN CUP
• Type of Device: PROTHESIS, HIPS
• 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: 17861926
• MDR Text Key: 324814331
• Report Number: 0001825034-2023-02296
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K140669
• 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,Followup,Followup
• Report Date: 01/18/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: HIP-UNK-CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 10/13/2023; 11/10/2023; 01/17/2024
• Supplement Dates FDA Received: 11/06/2023; 12/01/2023; 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 78 KG