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	10/07/2022
Type of Reportable Event	Serious Injury
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.Patient reports severe pain, difficulty with activities of daily living, difficulty ambulating with walker and has a limp and decreased range of motion.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Medical devices: g7 vit e neutral lnr 32mm e; item# 30103205; lot# 65224183, g7 pps ltd acet shell 52e; item# 010000663; lot# 7289876, and tprlc 133 fp type1 pps so 7.0; item# 51-100070; lot# 7240457.Report source: the netherlands.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the device remains implanted.The investigation is in process.Once the investigation is completed, a follow-up mdr will be submitted.Remains implanted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Medical records were not provided.Provided records were reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed with no complications noted.Two dislocations and both corrected with closed reduction.It was noted the patient experienced pain and difficulty with adl's.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty with cement fixation of the acetabular cup status post superior and posterior dislocation with subsequent reduction.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.

• 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: 15770126
• Report Number: 3002806535-2022-00463
• Device Sequence Number: 6584274
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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: 10/25/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 81 KG