MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL CENTRALIZER 13 MM O.D.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Osteopenia/ Osteoporosis (2651); Joint Impingement (4834)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 30103604 lot# 64797272 g7 vit e neutral lnr 36mm d.Cat# 00877503601 lot# 3031184 biolox⮠delta, ceramic femoral head, s, 㸠36/-3.5, taper 12/14.Cat# unknown lot# 838baf1806 refobacin bone cement.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 01038 the customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial right hip arthroplasty.Subsequently the patient reported a fall occurred on an unknown date and experienced pain and instability.Imaging revealed nonunion of greater trochanter fracture.The patient underwent a revision approximately 2.5 years after initial surgery.The shell was retained, as noted to be well fixed.Surgeon confirmed aspectic loosening at cement mantle, and patient had been experiencing anterior and posterior impingement.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.It was reported the patient fell due to unknown reasons and then reported pain, instability, noise, and discomfort.A revision was performed on where it was confirmed the stem was confirmed to have subsided and loosened.No immediate complications were noted.The head, stem, and liner were explanted and replaced.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic lucency surrounding the cemented component of the arthroplasty appears to be consistent with the reported history of aseptic loosening.It was reported the patient fell and began experiencing symptoms.However, as the reason for the fall is unknown, a definitive root cause cannot be determined.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
Event or Problem Description
No further information at the time of this report.

• Brand Name: DISTAL CENTRALIZER 13 MM O.D.
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16751614
• Report Number: 0001822565-2023-01039
• Device Sequence Number: 8528228
• Product Code: JDI
• UDI-Device Identifier: 00889024138704
• UDI-Public: (01)00889024138704(17)290930(10)64523861
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K955473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00785901300
• Device Lot Number: 64523861
• 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: 03/27/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 91 KG