MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 36MM; HIP ARTHROPLASTY

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: cer option type 1 tpr sleve +3, catalog #: 650-1067, lot #: 2959173, medical product: g7 neutral e1 liner 36mm e, catalog #: 010000857, lot #: 6515598.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00046.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent total hip arthroplasty.Subsequently, the patient underwent irrigation and debridement, where the liner and head components were removed and replaced.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00046.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.From the received response, the cause and type of the infection could not be confirmed.The action taken to cure the infection was to perform a head and liner swap with an irrigation debridement technique of surrounding tissues in hip.A review of the manufacturing history records confirms no abnormalities or deviations reported.The sterilisation certificates were reviewed and confirmed that product is sterilised within the specification range.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : product not returned.
Event or Problem Description
It was reported that patient underwent total hip arthroplasty.Subsequently, the patient underwent irrigation and debridement, where the liner and head components were removed and replaced.

• Brand Name: CER BIOLOXD OPTION HD 36MM
• Common Device Name: HIP ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9631496
• Report Number: 3002806535-2020-00045
• Device Sequence Number: 502642
• Product Code: LZO
• UDI-Device Identifier: 00887868248580
• UDI-Public: 00887868248580
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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 Model Number: N/A
• Device Catalogue Number: 650-1057
• Device Lot Number: 2958828
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/07/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention