MAUDE Adverse Event Report: BIOMET UK LTD. CALCAR PLANAR HEAD 38MM; BONE RASP

Model Number N/A

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product is available to be returned to zimmer biomet for investigation.Medical product: calcar planar shaft, catalog #: 110032332, lot #: 944540.Medical product: echo por fem red lat nc 13x145, catalog #: 192513, lot #: 261910.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00412.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 echo biometric rpp stem could not line up with the same size broach.No impact to the surgery.No consequences or impact to the patient.

Event Description

It was reported that the echo biometric rpp stem could not line up with the same size broach.No impact to the surgery.No consequences or impact to the patient.

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 reports: 3002806535-2020-00412-1.It was reported echo biometric rpp stem does not line up with same size broach.Did not affect surgery outcome or patient.Visual inspection of the returned product confirms that there are no visual issues relating to the reported event.The instrument appears to be in good condition with little wear or damage.The 110032332 calcar planar shaft - zimmer is not compatible with the echo biometric rpp stem instruments as reported in this complaint, this instrument is designed to be used with zimmer instruments only.The broach stem for the echo bi-metric stem system is a different diameter to the zimmer equivalent therefore will not fit.A review of the complaints database shows that we have received no reported event for implant position incorrect for the same item number 110032332 prior to the reported event.The severity of the reported event and calculated occurrence for this complaint are in line with the risk file.The overall score is negligible risk.Risk assessment: a.Severity assessment.The severity associated with the above line is 2.This gives a severity score of 2 (minor).B.Is actual severity in line with the risk file? the actual severity score is in line with the risk file.Occurrence rate assessment.A.September 2017 to september 2020.B.99509 items sold the given period.C.Complaints history search criteria.Part number review: search criteria: item number 110032332 & 110032335 and complaint category ¿implant position incorrect' complaint description ¿ reviewed for any position errors; number identified - 1 (including initiating complaint).Lot number review: search criteria: lot number ¿ 944940 & 560880.Complaint description ¿ reviewed for any relating to position errors; number identified - 1 (including initiating complaint).D.1 complaints reported during the time period.E.Occurrence ratio: 1:99509.Risk score: severity 2 x occurrence 1 = 2(negligible risk).

• Brand Name: CALCAR PLANAR HEAD 38MM
• Type of Device: BONE RASP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10527074
• MDR Text Key: 209369136
• Report Number: 3002806535-2020-00413
• Device Sequence Number: 1
• Product Code: GAC
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• 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: 110032335
• Device Lot Number: 560880
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEEH10