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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Subluxation (4525)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for evaluated of subluxation concerns of the right hip approximately one year and eight months post implantation.The patient complained of pain and a clunking sensation while lying prone.Additional physical therapy for hip strengthening was prescribed and the outcome is still pending.Attempts have been made and no further information is available.
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.
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: limb length and anatomical offset restored, excellent stability in all planes of motion, no impingement with trial and definitive components-appropriate component position and alignment were confirmed with fluroscopy.No complications, no immediate post-op radiographic findings.Patient in stable condition at end of procedure, wbat-plan to begin early ambulation with physical therapy.Contributing factors of event: advanced oa secondary to longstanding acetabular hip dysplasia.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: 18922324
• Report Number: 3002806535-2024-00103
• Device Sequence Number: 7598687
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: White