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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Osteolysis (2377); No Information (3190); Insufficient Information (4580)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

Cmp (b)(4).Source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the revision surgery was performed approximately one year eight months post procedure.They had removed exceed cup and replaced it by tmars system (cup and column implant).

Event Description

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

Manufacturer Narrative

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.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp) impressions: there is disruption of the medial wall of the acetabulum with displacement of the loose acetabular cup medially and medial displacement of the proximal femur.The components are dislocated.There is suspected osteolysis of the acetabulum.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Additional associated product and mdrs: unknown stem mdr: 0001825034-2021-01111.Unknown head mdr: 0001825034-2021-01112.Unknown liner mdr: 0001825034-2021-01114.  if any further information is found which would change or alter any conclusions, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN EXCEED CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11225430
• MDR Text Key: 228605538
• Report Number: 0001825034-2021-00175
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN EXCEED CUP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention