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

Catalog Number N/I

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial hip arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision due to unknown reasons.However, no revision procedure has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported that the patient is being considered for a revision due to instability of the acetabular cup and joint dislocation approximately 7 months post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

D10: unknown liner, unknown head.Multiple reports were submitted along with this report: 0001825034-2022-01524, 0001825034-2022-01525.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Radiographs were provided and reviewed by a health care professional.Review of the available records identified left total hip arthroplasty with dislocation of the acetabular cup, medial acetabular wall fracture and acetabular protrusio.The bone fracture likely caused the cup instability.Reported event was confirmed by review of x-rays provided.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.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.

• Brand Name: UNKNOWN CUP
• Type of Device: 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: 14218766
• MDR Text Key: 290164983
• Report Number: 0001825034-2022-00980
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: N/I
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2022
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 70 KG