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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

It was reported that patient underwent revision due to head and sleeve being lost in patient body during initial surgery.It was concluded that product may have traveled up into the abdomen.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Concomitant medical products: associated products: item number:51-107220,item name: tprlc 133 mp type1 pps ho 22.0, lot number:3616830, item number:110017109,item name:g7 finned 4 hole shell 64h, lot number:7115768, item number:98-b001-009-41,item name:unknown product, lot number: unknown, item number:30104008, item name:g7 vit e neutral lnr 40mm h, lot number:65100260, item number:650-1058, item name:cer bioloxd option hd 40mm, lot number:3096108, item number:650-1067, item name:cer option type 1 tpr sleve +3, lot number:3035290, item number:650-1066, item name:cer opt type 1 tpr sleve 0mm, lot number:3048726.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00482.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Medical records were not provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

Event Description

No further event information available at the time of this report.

• Brand Name: CER BIOLOXD OPTION HD 40MM
• Type of Device: PROSTHESIS, HIP
• 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: 15884337
• MDR Text Key: 304507030
• Report Number: 3002806535-2022-00481
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271403
• UDI-Public: (01)00887868271403(17)311215(10)3095934
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1058
• Device Lot Number: 3095934
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 12/09/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male