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

Model Number N/A

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

Patient Problem Hip Fracture (2349)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number: 00620205420 lot number: unknown brand name: tm modular cup, catalog number: 00630505036 lot number: 64036969 brand name: xlpe liners unknown head, unknown stem.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00352, 0001822565-2020-00353, 0001822565-2020-00354, 0001822565-2020-00355.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.Device remains implanted in the patient.

Event Description

It was reported that the patient was revised due to recurrent dislocation and acetabular cup loosening.It was noted that a trochanter fracture was noted to have occurred prior to revision.Additional information on the reported event is unavailable.

Manufacturer Narrative

Report source (b)(6).Reported event was confirmed by review of medical records noting patient underwent a previous revision along with two closed reductions for dislocation.Patient continued to dislocate and underwent a hip revision where the cup was found to be loos.A fracture of the greater trochanter was also noted during the procedure.Dhr was unable to be reviewed and the lot number for the device is unknown.The root cause is unable to 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.

Event Description

No additional event information to report at this time.

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9633270
• MDR Text Key: 176558463
• Report Number: 0001822565-2020-00354
• Device Sequence Number: 1
• Product Code: JDI
• 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: 04/21/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 04/09/2020
• Supplement Dates FDA Received: 04/22/2020
• 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