MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 18/140; HIP PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 06/05/2023

Event Type  Injury  

Event Description

It was reported that patient underwent right hip revision due to stem fracture which occurred while out walking about five (5) years after the initial surgery.No additional information or outcomes have been provided.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10 - avan reld acet shl ss ha 58mm, item# p0460p58, lot# 0001224269; avan uhmwpe insert 58/28, item# p0561058, lot# 0001300407; revitanâ®, proximal part, cylindrical, uncemented, 55, taper 12/14, item# 01.00402.055, lot# 947827; protasulâ®, s30 head, s, 㸠28/- 4, taper 12/14, item# 302805, lot# 2957272.G2 ¿ foreign ¿ germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

Upon reassessment of the reported event, it was determined that medwatch report should not have been filed due to complaint being duplicate of (b)(4) _medwatch # mdr339140.Report id: 0009613350-2023-00266.Given this information, this medwatch will be voided.

Manufacturer Narrative

(b)(4).Upon reassessment of the reported event, it was determined that medwatch report should not have been filed due to complaint being duplicate of (b)(4) medwatch # mdr339140.Report id: (b)(4).Given this information, this medwatch will be voided.

• Brand Name: REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 18/140
• 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: 17622867
• MDR Text Key: 321932917
• Report Number: 0009613350-2023-00493
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00889024592940
• UDI-Public: (01)00889024592940(17)230531(10)2954890
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.00406.118
• Device Lot Number: 2954890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2018
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male