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).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.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in united kingdom.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 and no product has been returned, however, visual inspection of the photographs provided through another complaint ((b)(4)) confirm a commingle has occurred.Ph-2020-00034 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 complaint database over the last 3 years has found 8 similar complaints reported with these items.A review of the manufacturing history records confirms no abnormalities or deviations reported.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: regulatory assessment determines that the occurrence of the event and the risk remains within the acceptable limits identified in the risk management report.Corrective action taken: ie-11715, hhed-2020-00082 & hhe-2020-00040 raised.Ph-2020-00034 has been raised to hold product affected by the issue.Preventive action taken no preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

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

Product has been returned and inspected.No product issue was detected.It is confirmed that labelling on the outer box matches the device.The event is not a commingle as reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay corrected information.Product has been returned and inspected.No product issue was detected.It is confirmed that labelling on the outer box matches the device as below: medical product: delta cer fem hd 28/-3mm t1; catalog 650-1159 lot 2019091306.Therefore, the event is not a commingle as previously reported.

• 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: 9841805
• MDR Text Key: 199062740
• Report Number: 3002806535-2020-00148
• Device Sequence Number: 1
• Product Code: JDI
• 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: 03/25/2021

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: 650-1159
• Device Lot Number: 2019091306
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 05/18/2020; 03/25/2021
• Supplement Dates FDA Received: 05/21/2020; 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other