MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZB ACETABULAR LINER; PROSTHETIC, HIP

Model Number N/A

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

Patient Problems Cellulitis (1768); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 110010243 g7 osseoti 3 hole shell 50mm d lot number: 6378467.193109 echo b-mtrc mp fp ho 9 lot number: 089870.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00988.0001825034 - 2023 - 00989.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted h3 other text : device location is unknown.

Event Description

It was reported that the patient had a revision procedure 2 months post implantation due to an infection.The acetabular liner, head and sleeve were exchanged, and the patient was placed on an antibiotic regimen.6 days post operatively, the patient had cellulitis, pain, erythema and swelling and was instructed to continue antibiotic regiment.The infection resolved 15 months later.At this time no further information is available, however per details available cup and stem remain implanted with no additional device related allegations known.There is no additional information at the time of this report.

Event Description

It was reported that the patient was seen for bursitis and treated with formal physical therapy and over the counter topical cream for ongoing pain.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: d6b: explant date provided in error.Corrected: h6: health effect clinical code, health effect impact code.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Bursitis is the inflammation or irritation of the bursae (the fluid filled sac that cushions the joint) and is typically caused by repetitive motion, overuse, and pressure to the bursae.Bursitis is a very common condition that can impact any of the joints and can last for a short duration or years.Symptoms the patient can experience include pain, tenderness, swelling, stiffness, decrease in movement, and/or redness at or around the joint that is involved.Conservative treatment consists of over the counter (otc) medication pain relievers and anti-inflammatories, rest, ice, elevation, and applying pressure wraps.If conservative treatments fail, physical therapy, aspiration, arthroscopy, or steroid injections may be necessary.The complaint indicates that postop bursitis developed and required medical intervention for treatment.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: UNKNOWN ZB ACETABULAR LINER
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16918525
• MDR Text Key: 315077800
• Report Number: 0001825034-2023-00990
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 010000856
• Device Lot Number: 6383738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White