MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM DIA COCR MOD HD -3MM NK; PROTHESIS, HIP

Model Number N/A

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

Patient Problems Nerve Damage (1979); Pain (1994)

Event Date 03/14/2023

Event Type  Injury  

Event Description

It was reported that approximately 1 month post implantation of a hip arthroplasty, the patient was revised due to sciatic pain.The cone body, head, and stem were explanted from the patient.Attempts have been made but no further information has been provided.

Manufacturer Narrative

(b)(4).D10: 11-301300 arcos con sz a std 50mm 270030.11-300915 arcos 15x190mm spl tpr dist 004150.010001000 g7 screw 6.5mm x 35mm 7309504.010000999 g7 screw 6.5mm x 30mm 7333331.010000913 g7 hi-wall e1 liner 28mm a 7099066.110010260 g7 osseoti multihole 44mm a 7240179.000-0163 pelvic screw std 116mm 9999999999.010000997 g7 screw 6.5mm x 20mm 7199540.Foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023 -01178.0001825034 -2023 -01214.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.

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.Updated: d4, g3, g6, h2, h3, h4, h6.H6: proposed component code: mechanical (g04) ¿ head.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.A review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined; however, the patient has a condition ddh that may have caused or contributed to the event.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.

• Brand Name: 28MM DIA COCR MOD HD -3MM NK
• Type of Device: PROTHESIS, HIP
• 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: 17010637
• MDR Text Key: 316022735
• Report Number: 0001825034-2023-01213
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 00887868308260
• UDI-Public: (01)00887868308260(17)320729(10)J7307527
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K942479
• 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
• Report Date: 08/30/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 163661
• Device Lot Number: J7307527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2022
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male