MAUDE Adverse Event Report: BIOMET UK LTD. BI-POLAR 28 CUP 41MM; FEMORAL HEAD BIPOLAR COMPONENT

Model Number N/A

Device Problems Component Missing (2306); Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the plastic component (insert) of the product was missing from the package.No patient involvement.No delay of the procedure.

Event Description

It was reported that the plastic component (insert) of the product was missing from the package.No patient involvement.No delay of the procedure.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in (b)(6).Product has been returned to biomet uk ltd for evaluation and forwarded to the complaints product evaluation engineer for investigation.The event reports that the liner component of a bipolar cup is missing.The complaint has been confirmed following review of the returned product provided and review of manufacturing history records.A review of the device history records identified discrepancies at the assembly step of the manufacturing process that have been confirmed to have contributed to the reported event.A complaint history review identified 3 similar complaints for the same item number, including (b)(4).This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.The confirmed condition of the device when it left zimmer biomet is non-conforming to specification.Risk assessment: a) severity assessment: since no appropriate line exists for this issue, no severity assessment can be made at this time.Product is subject to an fsca and ca-05623 initiated to investigate.B) occurrence assessment: (b)(4).-an occurrence assessment utilising sales cannot be compared to any risk file documentation as there is no appropriate line for this issue.Sales data for purposes of mir reporting are attached.C) risk score: risk score cannot be calculated or assessed without appropriate fmea line.Corrective actions: corrective action has been initiated as a result of the reported event; ca-05623 initiated for investigation of the root cause and implementation of corrective actions, and hhe-2020-00064 has been approved as a field safety corrective action for removal of the lot from the field.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.

• Brand Name: BI-POLAR 28 CUP 41MM
• Type of Device: FEMORAL HEAD BIPOLAR COMPONENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9796618
• MDR Text Key: 191589104
• Report Number: 3002806535-2020-00118
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 165206
• Device Lot Number: 6596871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1