MAUDE Adverse Event Report: BIOMET UK LTD. TRL MOD HD 36MM/-4MM (12/14); BMET GENERAL HIP INSTRUMENTS

Model Number N/A

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The product has been requested to 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.

Event Description

It was reported that the operator identified a mislabeled (trial head) during surgery.No delay of the procedure reported.No harm of the patient or the user has been reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Products have been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.The complaint can be confirmed that the taper depth is not to specification.Visual inspection of lot number zb170601 confirmed bearing surface shows signs of wear and damage and that part marking does not comply to specification as the lot or ce number has not been laser etched onto the trial head.Dimensional check confirms that the taper depth does not comply to the specification.The taper depth complies to specification for the +4mm trial head which is manufactured from black polycetalcopolymer (pom/c).Assembly check not required as dimensional inspection has confirmed non-conformance to specification.Material evaluation not required as complaint is not related to material failure or non-conformance.A comparison of the returned part (zb170601) against a stock part (zb160902), that complies to specification, shows the following disparities between the two parts: different font styles; no lot number engraved on the returned part; taper depth on returned part is not conforming to specification.The traceability of the part was investigated from the initial release by the manufacturing site, to receipt & issue to the kit by warsaw and then to a review of the kit bill of materials by the zimmer biomet srl loaner team in italy.It was not possible to confirm the control of the kit components whilst at the hospital (habilita casa di cura i cedri).Based on the review of the returned part against the specification, which specifies: machine engrave 36 and -4 in 4mm characters and mm & 12/14 in 2mm characters were shown to biomet spec 1.6.Laser mark lot no.And ce0086 in 2mm characters were shown to biomet spec 1.6.Based on the evidence available it cannot be confirmed that the returned part was a zimmer biomet manufactured product.Due to time in the hospital, the non-conformance to specification (dimensional & part marking/font style), we have cause to believe that the returned product is most likely not a zb manufactured product and that there has been a comingling of another manufacturers product with a zb kit caused by the user after post operation process.The control of the kit components are covered on the visual inspection instructions in the reusable instrument lifespan manual: inspection/function testing while loading instruments into their respective instrument cases after cleaning and prior to sterilization, reference the manual and follow the instructions below.Instruments should be inspected for completeness and function.Inspection includes inspecting for all forms of wear outlined in this manual.Results of assembly, actuation, and extent of all forms of wear should be considered in determining whether an instrument is suitable for use.If the reusable instrument is determined no longer suitable for use or if the suitability for use is still in question after inspecting the instrument and referencing the reusable instrument lifespan manual, initiate the process to return the instrument(s) to the manufacturer.The surgical technique instructs the user to select the correct provisional head that matches the stem taper, visually inspect the trial heads for damage prior to use, then select the appropriate head diameter and offset to create equal leg length and needed lateralization.The trial is then performed to assess leg length, range of motion, stability and abductor tension.This is repeated as necessary until optimal offset and leg length are established making any necessary adjustments to restore joint.The level of visual wear on the trial head suggests that the head has been used for a significant amount of time.From the information currently available there is no evidence to suggest that the product left the company non-conforming to specification or regulatory compliance.The dhr (dhr 31-600425 zb170601 inspection and release form) from the manufacturing site (zheijang, china) indicates, that after final inspection, that the product was released as conforming to specification.The product was then issued to the instrument kit rk-tap-comp-01-01 (400324741 3931012) by the kit build team in warsaw indiana.The bom (sap) confirms lot number at time of set creation on (b)(6) 2018 before shipment to the loaner team at zimmer biomet srl.(italy) and distribution to the customer.No non-conformances identified from the available information (dhr 31-600425 zb170601).No material/sterilisation review required as complaint is not related to material failure or non-conformance and these are not sterile parts.The complaint is not deemed as a zimmer biomet non-conformance and as such the hazard is not captured within the risk file (gen.Instr.Rmr.V4 & appendix 9 trials & gauges or appendix 11 instrument trays fmea).The risk is deemed as low.

Event Description

It was reported that the operator identified a mislabelled (trial head) during surgery.No delay of the procedure reported.No harm of the patient or the user has been reported.

• Brand Name: TRL MOD HD 36MM/-4MM (12/14)
• Type of Device: BMET GENERAL HIP INSTRUMENTS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11580730
• MDR Text Key: 246615151
• Report Number: 3002806535-2021-00097
• Device Sequence Number: 1
• Product Code: HWT
• 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,other
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

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: 31-600425
• Device Lot Number: ZB170601
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/29/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1