MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 28/-3MM T1; HIP PROTHESIS

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.

Event Description

It was reported that the size indicated on the implant did not match the size indicated on the package.There was no patient involvement.

Event Description

It was reported that the size indicated on the implant did not match the size indicated on the package.There was no patient involvement.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in united kingdom.D10: the product has not been returned to zimmer biomet for investigation.We contacted the hospital requesting the product to be returned.However, we have not received any response yet.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.The reported event has been determined to be a coob.The event reports that the labelling on the outer box did not match the device.No further information has been provided.No photographs of the implant have been provided andno product has been returned, however, visual inspection of the photographs provided through another complaint ((b)(4)) confirm a commingle has occurred.(b)(4) has been raised to hold product affected by the issue.Issue evaluation ie-11715 has been raised to further investigate the issue.Health hazard evaluation (determination) hhed-2020-0082 was raised which was escalated to hhe-2020-0040.A review of the manufacturing history records confirms no abnormalities or deviations reported.Risk assessment: according to pfmea #13 boxing and labeling rev.2 in process boxing and packaging exits the potential failure mode incorrect inserts that is classified: potential effect(s) of failure: insert not match with part/customer complaint.Potential causes: operator obtain incorrect material.Severity: 4 critical.Probability of occurrence: 2 rare (1 in 1.000 to 1 in 10.000 cases).Detectability (dia) 3 low (control is achieved with charting methods, such as statistical process control).Corrective action taken: ie-11715, hhed-2020-00082 & hhe-2020-00040 raised.Preventive action taken: no preventive action required at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : product has not been returned.

Manufacturer Narrative

(b)(4), this follow-up report is being submitted to relay corrected information.The following sections were updated: b5, d4, h1, h2, h4, h10.Product has been returned and inspected.It was identified that the lot number was incorrect.Lot #2019091307 not lot #2019091306.Correct medical product: delta cer fem hd 28/-3mm t1; catalog 650-1159; lot 2019091307 the identification of the correct lot number does not alter the outcome of our investigation.It can be confirmed that the inspected product is related to the reported event as both lot numbers are in scope of the health hazard evaluation raised in respect of the commingle.

Event Description

It was reported that the size indicated on the implant did not match the size indicated on the package.There was no patient involvement.

• Brand Name: DELTA CER FEM HD 28/-3MM T1
• Type of Device: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9842014
• MDR Text Key: 200636734
• Report Number: 3002806535-2020-00149
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1159
• Device Lot Number: 2019091307
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other