MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 32/0MM T1; PROSTHESIS, HIP

Catalog Number	650-1162
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Failure of Implant (1924)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2-foreign-belgium.D10.Item#: unknown; lot#: unknown; item name: unknown liner; item#: unknown; lot#: unknown; item name: unknown shell; item#: unknown; lot#: unknown; item name: unknown taperloc stem biomet; multiple mdr reports were filed for this event, please see the associated reports: 3002806535 - 2023 - 00443, 3002806535 - 2023 - 00444.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent revision surgery due to prosthetic fracture and heterotopic ossification.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b7, d9, d10, g3, g6, h2, h3, h11.D10 - associated medical devices: ringloc-x e1 std 50/32mm 23; item# ep-043250; lot# 3103574.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The ceramic head and poly liner were returned for evaluation.A visual inspection of the items was unable to confirm item/lot information on the ceramic head or the liner.The shell was not returned with this complaint.The liner was returned damaged and the ceramic head was fractured into several pieces with not all of the pieces being returned.There is also some galling on the id of the ceramic head where the neck taper would contact the head.Fracture analysis was performed on the returned ceramic head.Examination of the fractured head images provided shows metal transfer marks within the taper, as well as occasional metal transfer marks on other surfaces, likely from contact with the metal stem, acetabular shell and/or from contact with instruments during removal.The fracture surfaces looked irregular, with clean flat regions adjacent to rougher surfaces.The complexity of the fracture surfaces did not allow for the determination of the fracture initiation point.The root cause of the ceramic head fracture could not be determined in this instance.A review of the device manufacturing records for the ceramic head and poly liner confirmed no abnormalities or deviations that could be related to the reported event.A review of the device manufacturing records for the acetabular cup could not be performed due to the lot number being unknown.Medical records were provided and reviewed by a health care professional.The review identified the following: 17 days pre-revision x-ray report: no periprosthetic fracture, prosthetic fracture of the acetabular cup projecting inferior of the prosthetic head, increased ho superior of the major tuberculum, intact pelvic ring, moderate coxarthrosis on the left.10 days pre-revision ct report: fracture of prosthetic head with loose posterior fragment, no detachment of stem, intact acetabular cup and liner, some heterotopic ossification around the right hip.Revision op report: general + block.Posterolateral approach.2 large fragments and several smaller ceramic fragments were removed, extensive synovectomy with removal of more ceramic and polyethylene fragments.Stem well fixed, taperloc slightly damaged but remained implanted.Liner wear posteriorly with partial bony overgrowth, cup with pronounced bony overgrowth anteriorly that may have caused impingement.No complications 1 day post revision x-ray report: normal findings, good axle and position, no fracture with the available information, a definitive root cause could not 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: DELTA CER FEM HD 32/0MM T1
• Common Device Name: PROSTHESIS, HIP
• 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: 18354932
• Report Number: 3002806535-2023-00437
• Device Sequence Number: 6398655
• Product Code: LZO
• UDI-Device Identifier: 00887868271564
• UDI-Public: (01)00887868271564(17)230317(10)3002597
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/17/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/17/2023
• Device Catalogue Number: 650-1162
• Device Lot Number: 3002597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 04/01/2024; 05/14/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/15/2024; 04/29/2024; 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 83 KG