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

Device Problems Loose or Intermittent Connection (1371); Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Date 10/26/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03365; 0001822565-2023-03366.G2: south korea.D10: unknown biolox head; unknown screw; unknown liner.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported a patient underwent a left hip revision approximately five years post implantation due to pain, avascular necrosis, instability and loosening of the cup.The shell, screw, head and liner were exchanged without complications.Attempts have been made and no further information is available.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; g3; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed approximately 38 years ago with unk components.The first revision occurred approximately 32 years ago, where zb components were placed.A 2nd revision occurred approximately five years after implantation as the patient felt pain and visited the hospital.Avn, instability, and cup loosening was identified as well as normal bone quality.The cup, screw, liner, and head were explanted and replaced with no complications noted.The complaint is confirmed based on the review of the provided medical records.A definitive root cause cannot be determined for all issues excluding the avn.No problem was found for the devices related to the avn, as a review by a hcp determined it was not device related.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.

• Brand Name: UNKNOW CUP
• Type of Device: 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: 18237137
• MDR Text Key: 329367810
• Report Number: 0001822565-2023-03364
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/29/2023
• Supplement Dates FDA Received: 01/05/2024
• 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
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRITIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian