MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, CURVED, UNCEMENTED, 24/200; HIP PROSTHESIS

Model Number N/A

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Failure of Implant (1924)

Event Date 08/06/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that during implantation of the modular stem, the pin subsided and the proximal part could not me mounted, so the distal part had to be removed, causing a delay of two hours.Another implant was used and no further consequences or impact to the patient was reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified no scratches or nicks and no signs of damages.Dimensional analysis of the product found that the height of the press-in pin in the distal part was non-conforming to specifications.This was further confirmed by the functional test: the surface of the distal and proximal part come in contact, showing that the pin subsided in the distal part.The device history records for the distal component were reviewed.A deviation was noted; however, all impacted devices were scrapped.Device is used for treatment.Details on the surgical technique used were not provided, therefore the procedure cannot be assessed.With the available information a definitive root cause cannot be determined.As a result of the investigation, an issue evaluation and a product hold were initiated.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: REVITAN, DISTAL PART, CURVED, UNCEMENTED, 24/200
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 15508393
• MDR Text Key: 300866560
• Report Number: 0009613350-2022-00507
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024593091
• UDI-Public: (01)00889024593091(17)221031(10)2928919
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.00406.224
• Device Lot Number: 2928919
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 11/01/2022
• Supplement Dates FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2017
• 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): Required Intervention
• Patient Sex: Male