MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN BIOLOX DELTA HEAD; HIP PROSTHESIS

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown liner, unknown cup, unknown stem.Foreign source: south korea.Literature: moon, n.H., do, m.U., kim, j.S.Et al.The usefulness of dual mobility cups in primary total hip arthroplasty patients at a risk of dislocation.Sci rep 12, 774 (2022).Https://doi.Org/10.1038/s41598-022-04774-2.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported in a journal article that four patients, within the fixed bearing group, experienced a dislocation.No further discussion or information regarding intervention or outcome was provided.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Device is used for treatment.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.

Event Description

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

• Brand Name: UNKNOWN BIOLOX DELTA HEAD
• 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: 15417647
• MDR Text Key: 299852625
• Report Number: 3002806535-2022-00395
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

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: UNKNOWN BIOLOX DELTA HEAD
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 10/04/2022
• Supplement Dates FDA Received: 10/11/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose