MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEM HD 36/+3MM; BIOLOX DELTA CER FEM HD LG DIA

Model Number	N/A
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that: the patient underwent a hip arthroplasty on (b)(6) 2019.The patient was revised on (b)(6) 2022, due to undersized implant, loosening, and infection.
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The client has indicated that the product will not be returned to zimmer biomet for an investigation.Associated products: medical product: arcos 14x190mm spl tpr dist, catalogue number: 11-300914, lot number: 197870.Medical product: g7 osseoti multihole 60mm g, catalogue number: 110010268, lot number: 6512821 medical product: arcos con sz a std 70mm, catalogue number: 11-301321, lot number: 835680.Medical product: g7 neutral e1 liner 36mm g, catalogue number: 010000859, lot number: 6197089.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.Device discarded.
Event or Problem Description
It was reported, that: a patient underwent a hip arthroplasty on (b)(6) 2019.The patient was revised on feb 23, 2022, due to an undersized implant, loosening, and infection.
Additional Manufacturer Narrative
(b)(4).Complaint summary: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no related deviations or anomalies during manufacturing.The device is used for treatment.The reported products were reviewed for compatibility with no issues noted.Complaint history review for (b)(4) identified one (1) previous complaint with a similar complaint category (revision due to infection).Medical records/radiographs were provided and reviewed by a health care professional as part of a linked complaint: can you identify/confirm any signs of loosening, wear, radiolucency, or any other contributing factor such as malalignment that would cause issues with any of the components on the x-ray? no, none of the above is identified.Alignment is maintained.Can you comment on the appropriateness of the size of the implant relative to the patient¿s anatomy? on the image submitted, implant size appears appropriate.During the investigation process, a review of the sterile certifications and found to be conforming with no applicable deviations.Devices were verified to have gone through an acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that is outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.The investigation could not verify or identify any evidence of product contribution to the reported problem.  no corrective actions, preventive actions, or field actions resulted after the investigation of this event.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DELTA CERAMIC FEM HD 36/+3MM
• Common Device Name: BIOLOX DELTA CER FEM HD LG DIA
• 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: 13658216
• Report Number: 3002806535-2022-00088
• Device Sequence Number: 1944024
• Product Code: LZO
• UDI-Device Identifier: 00887868271182
• UDI-Public: 00887868271182
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-0662
• Device Lot Number: 2018060606
• 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: 02/23/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 89 KG