MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 18 HOLES, 363 MM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 3 years post implantation of a right total hip arthroplasty, the patient was revised due to pain and loosening.This patient has had multiple surgeries on this joint as well as the opposite joint.However, the type of surgeries and products involved in the previous surgeries were unspecified due to patient privacy laws.During the surgery, a plate was removed easily, and the stem was loose as expected, and was also easily removed.The joint was subject to aggressive debridement and prepped for new implants.The original cup and liner were left in situ.The revision surgery went as planned.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10 - medical devices: cat# 11-301321 lot# 394300 arcos con sz a std 70mm, cat# 163668 lot# 436570 32mm mod head cocr -3mm neck, cat# 11-301015 lot# 433780 arcos sts dist stem 15x250mm, cat# 00223200418 lot# 63981511 cable cerclage cable w/crimp 1.8 mm dia.635 mm length, cat# 47223206001 lot# 4502046392 ncba cable button for ncba polyaxial locking plate, 2.5 mm hex drive, cat# unknown lot# unknown ncb locking caps qty x 15, cat# unknown lot# unknown ncb 5mm unicortical screws - various lengths, cat# unknown lot# unknown ncb 5mm cortical screws - various lengths, cat# unknown lot# unknown ncb 4mm cortical screws - various lengths.G2 - foreign: new zealand.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.
Additional Manufacturer Narrative
(b)(4).No product was returned for investigation.Visual examination of the provided pictures identified that a small part of the ncb is fractured on one of the edge review of the device history records identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for this item and the reported part and lot combination a radiography was provided and reviewed by a health care professional.Review of the available records identified the following: implant alignment is maintained.No apparent loosening of the arthroplasty components.There is radiolucency along the two proximal fixation screws and along the proximal lateral femur/plate interface as noted and these screws may be loose.There are two proximal femoral defects as noted and questionable loosening of the proximal plate and screw fixation as described.With the available information a definitive root cause cannot be determined.
Event or Problem Description
No additional event information at this time.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 18 HOLES, 363 MM
• Common Device Name: PLATE, FIXATION, BONE
• 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: 17874638
• Report Number: 0009613350-2023-00555
• Device Sequence Number: 7182276
• Product Code: HRS
• UDI-Device Identifier: 00889024292710
• UDI-Public: (01)00889024292710(17)260731(10)2869414
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 02.02263.018
• Device Lot Number: 2869414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose