MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 38MM -6 NK; HIP PROTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Foreign report source: (b)(6).Customer has indicated that the product will not be returned returned to zimmer biomet for investigation as it has been discarded by the hospital.Concomitant medical products: medical product bi-metric hap 12x140 mm, catalog #: 162032, lot #: 1772937.Medical product:-m2a-38 cup non flared sz 52mm, catalog #: 15-106052, lot #: 143810.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00231.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
Event or Problem Description
It has been reported by clinical study for eu11 ceramic-on-metal v mom using m2a-38 cup in cementless tha (339) that the patient initially underwent a right total hip arthroplasty.Subsequently, the patient was revised on due to pseudotumors and infection.The patient was then removed from the study due to revision of components.
Event or Problem Description
It has been reported by clinical study for eu11 ceramic-on-metal v mom using m2a-38 cup in cementless tha (339) that the patient initially underwent a right total hip arthroplasty.Subsequently, the patient was revised on due to pseudotumors and infection.The patient was then removed from the study due to revision of components.
Additional Manufacturer Narrative
(b)(4).Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current manufacturer for this product (item: 12-115130).This product will be reported by medwatch facility warsaw biomet ¿ (b)(4).

• Brand Name: CER BIOLOXD MOD HD 38MM -6 NK
• Common Device Name: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9937947
• Report Number: 3002806535-2020-00230
• Device Sequence Number: 16318777
• Product Code: LPH
• UDI-Device Identifier: 05019279316144
• UDI-Public: 05019279316144
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2020

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 Expiration Date: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 12-115130
• Device Lot Number: 1620263
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 64