MAUDE Adverse Event Report: BIOMET UK LTD. CER OPTION TYPE 1 TPR SLEVE +3; HIP PROTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report unique identifier (udi) number: (b)(4).Concomitant medical products: cat# 650-1068 cer bioloxd option hd 40mm lot# 2993794.Cat# 30124009 g7 vit e high wall lnr 40mm i lot#64714864.Cat# 110010271 g7 osseoti multihole 66mm i lot# r3713970a.Cat#11-300817 arcos 17x150mm spl tpr dist lot#838140.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00043.
Event or Problem Description
It was reported the patient underwent a hip revision approximately 11 months post implantation due to an infection.No additional information.
Event or Problem Description
It was reported that a patient underwent an initial hip procedure on (b)(6) 2019.The patient has since received multiple revision procedures.Subsequently, a revision procedure due to infection was performed on (b)(6) 2021.The revised implants were implanted on (b)(6) 2020.No further information available.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated report 3002806535-2021-00043-01.As the product has not been received, the investigation was limited to the information provided.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of complaint history was assessed for three years prior to the notification date and identified (9) total complaints for item 650-1058.There were (0) additional complaints against the lot 2993794.A review of complaint history was assessed for three years prior to the notification date and identified ((b)(4)) total complaints for item 650-1067.There were (0) additional complaints against the lot 3031101.No trends were identified from complaint history review for the items 650-1067.For the item 650-1058, (b)(4) complaints were reported with same hospital.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Risk assessment: the root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk table could not be selected for comparison.The reported event states that the revision was performed due to infection.Although the root cause could not be determined, infection is captured multiple times within the ceramics head risk table with a severity score no greater than 3 (moderate).The outcome of this complaint (surgical intervention) is considered to be within the severity of the rmf.If further information regarding the root cause of the reported event is provided, risk should be re-assessed.

• Brand Name: CER OPTION TYPE 1 TPR SLEVE +3
• Common Device Name: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11365279
• Report Number: 3002806535-2021-00044
• Device Sequence Number: 11408293
• Product Code: LPH
• UDI-Device Identifier: 00887868271496
• UDI-Public: 00887868271496
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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: 650-1067
• Device Lot Number: 3031101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/01/2021
• 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
• Patient Age: 45 YR