MAUDE Adverse Event Report: ZIMMER GMBH REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 75, TAPER 12/14; N/A

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Information (3190)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states under 510(k) number: k071723.Dhr-review: ref: 01.00401.075 ; lot:2853916.(b)(4).The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: wrong laser marking on device event description: it was reported that after opening the package of the revitan prox.Part it was detected that the text ¿demo¿ is on the implant.There was no "demo" indication on the outer packaging.Review of received data: - the received picture shows a revitan prox.Part with the laser marking "demo" on it whereas on the patient labels (ref: 01.00401.075 ; lot: 2853916) no "demo" is indicated.Devices analysis: - the visual examination confirms that on the neck of the revitan prox.Part the inscription "demo" is laser marked.The returned packaging box with the product label shows the "normal" label of item 01.00401.075.Review of product documentation: - a demo device is only available for the length 75mm of the product family proximal part spout (lmplant 01.00401.075) and proximal part cylindrical (lmplant 01.00402.075).The demo device has also a different ref number as the implants (demo ref nr.01.00400.075).The only difference between the implant and the demo product is the laser marking 'demo' on the product and that the demo product (item 01.00400.075) is delivered and packed non-sterile.The incorrect laser marked implant reported from the complaint went trough all process steps at zimmer biomet winterthur of a sterile implant and also meet all specification for item 01.00401.075 revitan prox.Spout 75.Conclusion summary: it was reported that after opening the package of the revitan prox.Part it was detected that the text ¿demo¿ is on the implant.There was no "demo" indication on the outer packaging.Checking the received photos and the returned devices it could be confirmed that on the neck of the revitan prox.Part the inscription "demo" is laser marked whereas the returned packaging box with the product label shows the "normal" label of item 01.00401.075.The root cause of this issue is a manufacturing/laser marking issue.Based on the investigation results internal corrective actions were initiated.A field safety corrective action was initiated.The usa are not affected by this fsca.The affected piece from (b)(4) was returned on 07.Feb.2018 via complaint handling process.Zimmer (b)(4) considers this case as closed.(b)(4).

Event Description

It was reported that after the opening of the package of the revitan, proximal part, conical, uncemented, 75, taper 12/14 the implant was marked with "demo".On the outer packaging was no indication for the demo article.It was also reported that there was no impact to patient.

• Brand Name: REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 75, TAPER 12/14
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7859764
• MDR Text Key: 120109466
• Report Number: 0009613350-2018-01008
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 01.00401.075
• Device Lot Number: 2853916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other