MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER ELEVATED RIM 36 MM I.D. SIZE LL FOR USE WITH 58 MM O.D. SIZE LL SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Hearing Impairment (1881); Pain (1994); Visual Impairment (2138); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.Concomitant medical products: item number: 00786401420, item name: femoral stem press-fit, lot #: 63207151.Item number: 00875705801, item name: shell with cluster holes, lot #: 632383,50.Item number: 00877503602, item name: biolox⮠delta, ceramic femoral head, m, 㸠36/0, taper 12/14, lot #: 2924385.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 05599, 0001822565 - 2018 - 05601.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient is experiencing severe pain, balance, vision impaired, hearing impairment, weak, severe groin pain, extreme pain where incision, instability and limited mobility post-implantation.There has been no reported intervention at this point.Attempts have been made and no additional information is available.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi#: (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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.

• Brand Name: LINER ELEVATED RIM 36 MM I.D. SIZE LL FOR USE WITH 58 MM O.D. SIZE LL SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7947891
• MDR Text Key: 123114477
• Report Number: 0001822565-2018-05600
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK151448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

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 Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00875201336
• Device Lot Number: 63145338
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 10/09/2018
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 91