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

Model Number N/A

Device Problem Insufficient Information (3190)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item #: unknown, unknown liner, lot #: unknown; item #: unknown, unknown head, lot #: unknown; item #: unknown, unknown cup, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03122, 0001822565 - 2020 - 03123, 0001822565 - 2020 - 03124.

Event Description

It was reported that patient underwent an initial left total hip arthroplasty and has now been indicated for a revision approximately 8 years post primary implantation.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

Reported event was unable to be confirmed due to limited information received from the customer.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.Radiographs review identified the following : radiolucency along the proximal femoral component.Osteopenia was observed.No other findings related to the reported event were noted.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

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

• 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: 10483897
• MDR Text Key: 205336881
• Report Number: 0001822565-2020-03121
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

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?: Yes
• 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: 08/25/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ITEM: UNKNOWNUNKNOWN ZMR CONE BODYLOT: UNKNOWN; SEE H10
• Patient Outcome(s): Other