MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN REVITAN STEM DISTAL PART; HIP PROSTHESIS

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 08/07/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - associated products: unknown revitan stem proximal part; item# unknown: lot# unknown.G2 - foreign: switzerland.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.H3 other text : product information unknown.

Event Description

It was reported that the patient underwent a revision surgery due to the fractured conical part of the stem.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

No additional information at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6.No products were returned to the post market surveillance team for examination.However, two images showing the reported product and confirming the reported event of pin fracture have been received.The connection pin of the distal part of the revitan stem has fractured in the non-blasted area.One image shows the fracture surfaces of both the distal and proximal parts.Macroscopically, as far as visible, no defects that could have triggered or favored the fracture were found on the fracture surfaces.The seating surface as well as the fracture surface of the distal part however does show some polished surfaces, which could have occurred after the fracture.On the other image provided, no bone-ongrowth is evident on the proximal part.There appears to be some indication of bone on-growth and/or scratches and nicks on the distal part.However, due to the quality of the image, no clear judgement can be made.No femoral head is mounted on the proximal part of the revitan stem.A review of the device manufacturing records could not be performed due to missing lot number.A review of the complaint history could not be performed due to missing reference and lot numbers.Due to the lack of available information, a definitive root cause cannot be determined.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.H3 other text : no product information available.

• Brand Name: UNKNOWN REVITAN STEM DISTAL PART
• 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: 17834436
• MDR Text Key: 324481822
• Report Number: 0009613350-2023-00537
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose