MAUDE Adverse Event Report: ZIMMER GMBH NCB®, LOCKING CAP; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 12/20/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10.Ncb, locking cap, item# 0202150300, lot# 3034939.Ncb, locking cap, item# 0202150300, lot# 3059655.Ncb, periprosthetic femur plate, proximal, right, short, 115 mm item# 0202263000, lot# 2934192.Ncb, periprosthetic trochanter plate, right, narrow item# 0202263201, lot# 3028988.Arcos 15x190mm spl tpr dist, item# 11-300915, lot# 977420.36mm cocr mod hd +3mm, item#11-363663 lot# 553440.Unknown liner.Cable cerclage cable with crimp 1.8 mm dia.635 mm length, item# 00223200418, lot# unknown.3.5 mm locking screw 14 mm, length item#00236901435, lot# unk.3.5 mm locking screw 38 mm, length item# 00236903835, lot# unk.3.5 mm locking screw 44 mm, length item# 00236904435, lot# unk.Long ost blade 10mm x 5, item# 47-9986-021-26, lot# 56715038.3.5 mm locking screw 16, mm length, item# 00236901635, lot# unk.3.5 mm locking screw 22, mm length, item# 00236903035, lot# unk.Ncb unicortical scr 5.0 l=16mm, item# 02.03151.016, lot# unk.Ncb unicortical scr 5.0 l=18mm, item# 02.03151.018, lot# unk.Ncb unicortical scr 5.0 l=20mm, item# 02.03151.020, lot# unk.G2.Report source: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2024-00094.

Event Description

It was reported that an initial hip arthroplasty was performed approximately two years ago.Subsequently the patient underwent a revision surgery as the as the cup had migrated medially, the stem was loose, and there was an unspecified infection.Attempts have been made it and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable as it was confirmed that the reported event was unrelated to the reported zb device.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable as it was confirmed that the reported event was unrelated to the reported zb device.The initial report was forwarded in error and should be voided.

• Brand Name: NCB®, LOCKING CAP
• Type of Device: PROSTHESIS, HIP
• 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: 18887744
• MDR Text Key: 337462493
• Report Number: 0009613350-2024-00093
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K192217
• 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: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 0202150300
• 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: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention
• Patient Sex: Male