MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 40MM; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	07/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: cer option type 1 tpr sleve +6 catalog #: 650-1068 lot #: 2959195.Associated devices medical product: tprlc 133 t1 pps ho 13x146mm catalog #: 51-104130 lot #: 6498655, medical product: g7 pps ltd acet shell 60g catalog #: 010000667 lot #: 6555005, medical product: g7 neutral e1 liner 40mm g catalog #: 010000865 lot #: 6233683.Remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00812.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.Products in the process of being returned.
Event or Problem Description
It was reported that patient underwent primary left tha.It was reported that the patient experienced orthostatic hypotension and this delayed the patients discharge from the hospital.Attempts were made to obtain additional information; however, none was available.
Additional Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
Event or Problem Description
It was reported that patient underwent primary left tha.It was reported that the patient experienced orthostatic hypotension and this delayed the patients discharge from the hospital.Attempts were made to obtain additional information; however, none was available.

• Brand Name: CER BIOLOXD OPTION HD 40MM
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9165937
• Report Number: 3002806535-2019-00811
• Device Sequence Number: 14120609
• Product Code: LZO
• UDI-Device Identifier: 00887868248597
• UDI-Public: 00887868248597
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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: 650-1058
• Device Lot Number: 2982740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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
• Patient Weight: 104