MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEM HD 36/0MM; BIOLOX DELTA CER FEM HD LG DIA

Model Number N/A

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

Patient Problem Pulmonary Embolism (1498)

Event Date 04/28/2021

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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that: initial right total hip arthroplasty performed (b)(6) 2021.Subsequently, the patient developed a pulmonary embolism on (b)(6) 2021, requiring 1 day hospitalization.Pe resolved without further complication.Upon follow-up, the patient reported no problems and was very satisfied.Patient involved.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: adequate photographs have not been provided and product the has not been returned for evaluation.Therefore, the investigation has been limited to the information provided and a complaint history search.A review of the device history record and raw material cert identified no deviations or anomalies during manufacturing that could be related to the reported event.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.A review of complaint history identified no additional similar complaints about the reported item and no additional complaints about the reported item and lot combination.Medical records or x-rays are not relevant for this event.The likely condition of the device when it left zimmer biomet is conforming to the specification.The reported event has not been confirmed as relevant photographs have not been provided and the product has not been returned for evaluation.The definitive root cause of this event cannot be determined with the available information.It has been confirmed that the implant is not within the scope or subject of any ie's, capa, field actions or recalls which could be attributed to the reported event.Corrective or preventative action is not required as the root cause of the reported event cannot be determined with the information provided.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be tendered accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported, that: an initial right total hip arthroplasty was performed on (b)(6) 2021.Subsequently, the patient developed a pulmonary embolism on 28-apr-2021, requiring 1-day hospitalization.Pe resolved without further complication.Upon follow-up, the patient reported no problems and was very satisfied.Patient involved.

• Brand Name: DELTA CERAMIC FEM HD 36/0MM
• Type of Device: BIOLOX DELTA CER FEM HD LG DIA
• 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: 14368992
• MDR Text Key: 291482019
• Report Number: 3002806535-2022-00241
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868355875
• UDI-Public: 00887868355875
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

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: 650-0661
• Device Lot Number: 3035182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 05/12/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2020
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 28 YR