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

Model Number N/A

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Osteopenia/ Osteoporosis (2651); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item #: unknown, unknown head lot #: unknown; item #: unknown, unknown liner lot #: unknown; item #: unknown, unknown acetabular plate lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the 411 group the patient underwent an initial tha at an unknown date.The patient has been indicated for a revision, however, a revision has not been reported.The sales rep was inquiring about implant identification.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.Updated: b4, b5, d11, g4, h2, h3, h6 d11: item #: unknown unknown screw lot #: unknown item #: unknown unknown screw lot #: unknown item #: unknown unknown screw lot #: unknown multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02859 0001822565 - 2020 - 02862 0001822565 - 2020 - 02864 0001822565 - 2020 - 02865 reported event was confirmed by radiographs.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Radiograph review shows multiple fractured screws are seen along the acetabular reconstruction with loosening of the plate.Femoral stem is intact with lucent oblique fracture line involved in the mid-femoral diaphysis.Bony resection or resorption of the proximal femoral diaphysis is present.Mild osteopenia is present.Acetabular reconstruction limits evaluation for acetabular cup angles.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported by the 411 group the patient underwent an initial tha at an unknown date.The patient has been indicated for a revision, however, a revision has not been reported.The sales rep was inquiring about implant identification.Radiograph review indicates loose acetabular plate, fractured screws, and bone loss in femur.No additional information is available.

• 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: 10264218
• MDR Text Key: 198873686
• Report Number: 0001822565-2020-02541
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• 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
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10; SEE H10
• Patient Outcome(s): Other