MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 28MM; HIP PROSTHESIS

Model Number N/A

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

Patient Problems Pain (1994); Local Reaction (2035)

Event Date 09/19/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure of the left hip due to a pseudotumor.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Concomitant medical products: bearing 28 mm i.D.46 mm o.D.Size g , item# 110031001 , lot# 64515040.Cer option type 1 tpr sleve +6 , item# 650-1068 , lot# 3063681.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 -2022 -00425.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

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

Manufacturer Narrative

(b)(4).No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records relevant to the right total hip arthroplasty identified the following: the right total hip arthroplasty appears intact.No bone or hardware fracture.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CER BIOLOXD OPTION HD 28MM
• Type of Device: HIP PROSTHESIS
• 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: 15624401
• MDR Text Key: 301909113
• Report Number: 3002806535-2022-00432
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271373
• UDI-Public: (01)00887868271373(17)311025(10)3087211
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200959
• 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
• Report Date: 11/03/2022

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 650-1055
• Device Lot Number: 3087211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 11/02/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 90 YR
• Patient Sex: Female