MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 32/-3MM T1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical devices: g7 vit e neutral lnr 32mm e; item# 30103205; lot# 65224183.G7 pps ltd acet shell 52e; item# 010000663; lot# 7289876.Tprlc 133 fp type1 pps so 7.0; item# 51-100070; lot# 7240457.G2 - foreign: the netherlands.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.Device is used for treatment.Medical records were provided and reviewed by a health care professional.Contributing factors of event: pain, difficult with adl¿s, decreased rom, multiple dislocations, right hip revision due to multiple dislocation.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.
Event or Problem Description
It was reported that the patient experienced a dislocation approximately 15 days post right total hip arthroplasty and was corrected with a closed reduction.Subsequently, the patient experiences the second dislocation approximately 3 weeks later which was also corrected with a closed reduction.Subsequently, a revision surgery was performed approximately a month later due to recurring dislocations.Patient reports severe pain, difficulty with activities of daily living, difficulty ambulating with walker and has a limp and decreased range of motion.Attempts have been made and no further information has been provided.

• Brand Name: DELTA CER FEM HD 32/-3MM T1
• 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: 16830905
• Report Number: 3002806535-2023-00126
• Device Sequence Number: 20628255
• Product Code: LZO
• UDI-Device Identifier: 00887868271571
• UDI-Public: (01)00887868271571(17)320523(10)3115034
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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: 650-1163
• Device Lot Number: 3115034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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: Female
• Patient Weight: 81 KG