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

Catalog Number 650-1162

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Subluxation (4525)

Event Date 10/04/2023

Event Type  Injury  

Event 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.

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.

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 Description

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

• Brand Name: BIOLOX DELTA CER FEM HD 32/0MM T1
• 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: 18922324
• MDR Text Key: 337881558
• Report Number: 3002806535-2024-00103
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271564
• UDI-Public: (01)00887868271564(17)310819(10)3084053
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2021
• 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 Age: 48 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: White