MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN WAGNER CONE STEM; HIP PROSTHESIS

Model Number N/A

Device Problem Osseointegration Problem (3003)

Patient Problem Failure of Implant (1924)

Event Date 10/20/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - unknown hook roof shell, item# unknown, lot# unknown.Report source ¿ foreign ¿ switzerland.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00655.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 a patient underwent a hip revision surgery due to no bone in-growth and instability approximately one and half years after the initial surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.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 a patient underwent a hip revision surgery due to no bone in-growth and secondary dislocation approximately one and half years after the initial surgery.No further event information available at the time of this report.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the provided picture identified confirms an unknown wagner stem and an unknown hook roof shell.There is evidence of some bone growth to the stem.In addition, an unknown ceramic head and one screw are present in the photograph.The ceramic head shows signs of what appear to be metal transfer marks.There is an unknown bearing component which appears to be fractured with one piece remaining within the shell.It is unknown where the pieces which have broken off are as they are not photographed.Due to the poor quality of the provided photograph, no further observations can be made.Part and lot identification are necessary for review of device history records, neither were provided.Devices are used for treatment.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ap view of the bilateral hips demonstrates a left total hip arthroplasty with acetabular reconstruction.Loosening of the acetabular reconstruction with two fractured screws superiorly.Significant gap in between the hardware and bone.Possible bony fragments or liner fragments inferior to the femoral neck.Proximal cerclage wire within the femoral stem.There is no indication within the hcp radiograph review of a loosening of the femoral component.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.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.D10 - reinforcement ring with hook, 46, item# 94162346, lot# 2925281; cancellous bone screw 35, item# 418.035, lot# 8445110; cancellous bone screw 35, item# 418.035, lot# 3219020; ao ti canc bone screw 40m, item# 418.040, lot# 8521390; ao ti canc bone screw 50m, item# 418.050, lot# 5l54090; unknown ceramic liner, item# unknown, lot# unknown; unknown ceramic head, item# unknown, lot# unknown.A stem, a reinforcement ring with hook, a ceramic head, four screws and a cerclage wire have been returned for evaluation.The reinforcement ring with hook shows few nicks and scratches probably due to the revision surgery.Some screw holes of the ring are completely covered by bone cement.The visual examination revealed polished areas including shiny polished spots and lines on the anchoring side as well as on the inside of the reinforcement ring.The different polished areas could point to signs of loosening.Three of the four returned screws are fractured.Polished areas can be recognized.The stem and the head are competitor product manufactured by mathys.Both show several scratches that probably occurred during the revision surgery.There are bone residues visible on the stem.A review of the device manufacturing records for the reinforcement ring with hook confirmed no abnormalities or deviations that could be related to the reported event.Devices used for treatment.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ap view of the bilateral hips demonstrates a left total hip arthroplasty with acetabular reconstruction.Loosening of the acetabular reconstruction with two fractured screws superiorly.Significant gap in between the hardware and bone.Possible bony fragments or liner fragments inferior to the femoral neck.Proximal cerclage wire within the femoral stem.There is no indication within the hcp radiograph review of a loosening of the femoral component.Based on the returned products, a definitive root cause cannot be determined.However, off-label use has been performed while implanting the devices.It remains unknown if the non-approved product combination might have contributed to the reported event.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.

• Brand Name: UNKNOWN WAGNER CONE STEM
• 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: 15993855
• MDR Text Key: 305584165
• Report Number: 0009613350-2022-00656
• Device Sequence Number: 1
• Product Code: MRA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 89 KG