MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN 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)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet as 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: 0001825034-2020-02982, 0001825034-2020-02983, 0001825034-2020- 02984.

Event Description

It was reported that patient underwent a hip revision after an unknown amount of time post implantation due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event is unable to be confirmed due to limited information provided by the customer.Dhr was unable to be reviewed as 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.

Event Description

It was reported that patient underwent a second right hip revision approximately 13 years after the first due to pain, osteolysis, and loosening of the screw causing wear on the liner.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D6: implanted (b)(6) 2007.An updated investigation is in process and a follow-up mdr will be submitted upon completion.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03760.

• Brand Name: UNKNOWN CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10338675
• MDR Text Key: 200845817
• Report Number: 0001825034-2020-02981
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2020

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: 07/08/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 08/25/2020; 09/18/2020; 11/05/2020
• Supplement Dates FDA Received: 08/26/2020; 10/12/2020; 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN SCREW; UNKNOWN STEM; UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN STEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 83