MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MULTIPOLAR SHELL 47 MM O.D.; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date (b)(6) or (b)(6) of 2018.Concomitant medical products: 00785701300 ¿ versys femoral stem ¿ unknown lot, 00801802802 ¿ cocr head ¿ unknown lot, 00500104728 ¿ bipolar liner ¿ unknown lot.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.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 - 2019 - 04472, 0002648920 - 2019 - 00751, 0001822565 - 2019 - 04477.

Event Description

It was reported that patient is experiencing aches and pains, loss of balance, difficulty walking, chronic fatigue, stomach upset, reflux, erratic blood pressure, spasmodic confusion, headaches, and heart thumping approximately 5 or 6 months post right hip bipolar arthroplasty.No revision surgery has been reported to date.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.Reported event was unable to be confirmed due to limited information provided by the customer.Dhr review was unable to be performed as the lot number for the device is unknown.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.

Manufacturer Narrative

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0002648920 - 2021 - 00309.

Event Description

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0002648920 - 2021 - 00309.

• Brand Name: MULTIPOLAR SHELL 47 MM O.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9198213
• MDR Text Key: 162627703
• Report Number: 0001822565-2019-04478
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• 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: 00500104700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Age: 88 YR