MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 28MM; BIOLOX DELTA CERAMIC OPTION HD

Model Number N/A

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 09/05/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Associated products: medical product: g7 osseoti 3 hole shell 50mm d.Catalog no.: 110010243.Lot no.: 65028789.Medical product: g7 dual mobility liner 40mm d.Catalog no.: 110024462.Lot no.: 601920.Medical product: echo por fem red lat nc 11x135.Catalog no.: 192511.Lot no.: 808080.Multiple mdr reports were filed for this event, please see associated: 3002806535-2021-00449.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.

Event Description

It was reported, that an initial right total hip arthroplasty was performed (b)(6) 2021.Subsequently, the patient experienced drainage from the wound and was rehospitalized (b)(6) 2021 due to superficial wound infection.A wound vac was applied, and the patient was discharged 5 days later.Upon follow up, the patient was very satisfied with minimal pain.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: adequate photographs have not been provided and product has not been returned for evaluation.Therefore, the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.Review of complaint history identified 10 additional similar complaints for the reported items and no additional complaints for the reported item 650-1055 and lot 3062797 combination & 650-1065 and lot 3048720 combination.These devices are used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.These part and lot combinations are not associated with any recalls at the time the search was conducted.The likely condition of the devices when it/they left zimmer biomet is conforming to specification.The reported event has not been confirmed as relevant photographs have not been provided and packaging has not been returned for evaluation and the dhr review did not identify any issues.The root cause of the reported event can not be determined with the information provided.Corrective or preventative action not required.The root cause of the reported event can not be determined with the information provided.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2021-00449-1.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported, that: initial right total hip arthroplasty performed (b)(6) 2021.Subsequently, the patient experienced drainage from the wound and was re-hospitalized (b)(6) 2021 due to superficial wound infection.A wound vac was applied, and the patient was discharged 5 days later.Upon follow up, the patient was very satisfied with minimal pain.Patient outcome - infection.

• Brand Name: CER BIOLOXD OPTION HD 28MM
• Type of Device: BIOLOX DELTA CERAMIC OPTION HD
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12645665
• MDR Text Key: 276834960
• Report Number: 3002806535-2021-00448
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271373
• UDI-Public: 00887868271373
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

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
• Device Catalogue Number: 650-1055
• Device Lot Number: 3062797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEEH10
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 115 KG