MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEM HD 36/+3MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical devices: 36mm i.D.Size e neutral; item# 30103605; lot# 65516876.G7 pps ltd acet shell 52e; item# 010000663; lot# 7311439.Tprlc 133 t1 pps ho 12x144mm; item# 51-104120; lot# 6992221.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 or Problem Description
It was reported that a patient underwent an initial left total hip arthroplasty.Subsequently, two weeks later the patient was revised due to fractured femoral head with poly damage.The poly liner and femoral head were revised without complications.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Visual examination of the provided pictures identified that the ceramic femoral head appears to be fractured in 3 pieces and there appears to be metal transfer on the internal diameter surface from the stem taper.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records were provided and reviewed by a health care professional.Patient reported that they "felt a clunk" while reaching for the cupboard, but reported no trauma.An evaluation carried out prior to the revision showed what appeared to be a fractured ceramic head.During revision surgery the ceramic femoral head was reported to be fractured into 3 pieces.Acetabular and femoral stem component were well aligned and well fixed but damage to the liner was reported.With the available information, 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.
Additional Manufacturer Narrative
(b)(4).Upon reassessment of the reported event, it was determined a medwatch report should not have been filed because the event is a duplicate of a previously reported incident.This event has previously been reported under mfr report number 3002806535-2022-00512.Given this information, this medwatch will be voided.
Event or Problem Description
Upon reassessment of the reported event, it was determined a medwatch report should not have been filed because the event is a duplicate of a previously reported incident.This event has previously been reported under mfr report number 3002806535-2022-00512.Given this information, this medwatch will be voided.

• Brand Name: DELTA CERAMIC FEM HD 36/+3MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 17207345
• Report Number: 3002806535-2023-00210
• Device Sequence Number: 20481049
• Product Code: LZO
• UDI-Device Identifier: 00887868271182
• UDI-Public: (01)00887868271182(17)320701(10)3119039
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2023

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 Model Number: N/A
• Device Catalogue Number: 650-0662
• Device Lot Number: 3119039
• Was Device Available for Evaluation?: No
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 07/31/2023; 11/01/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/02/2023; 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male