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

Catalog Number	650-1162
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: g7 pps ltd acet shell 50d; item# 010000662; lot# 7067118.Tprlc 133 fp type1 pps ho 5.0; item# 51-101050; lot# 3799117.32mm i.D.Size d neutral liner; item# 30103204; lot# 64922381.Bone screw self-tapping 6.5 mm dia.25 mm length; item# 00625006525; lot# j7053823.Unknown apical hole plug; item# unknown; lot# unknown.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 the patient underwent an initial right total hip arthroplasty.Subsequently, following a fall due to unknow reasons, the patient visited the emergency room approximately one year and two months post the initial surgery.The patient was experiencing pain and difficulty with mobility.Imaging diagnosed a contusion and medication was given for pain management.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Medical records were provided and reviewed by a health care professional.The review identified: patient presented to er with acute exacerbation of hip pain after a fall 2 days prior, pain is worsening and radiates, patient has been using a crutch to assist her.On exam no deformity, leg shortening, or neurovascular deficit, rom intact.Ct performed due to poor mobility despite negative x-rays-also negative, no evidence of loosening or fracture.Diagnosed with contusion (bruise), resolved with elevation and icing.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: BIOLOX DELTA CER FEM HD 32/0MM T1
• Common Device Name: 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: 18921487
• Report Number: 3002806535-2024-00101
• Device Sequence Number: 6410612
• Product Code: LZO
• UDI-Device Identifier: 00887868271564
• UDI-Public: (01)00887868271564(17)310819(10)3084053
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 650-1162
• Device Lot Number: 3084053
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: White