MAUDE Adverse Event Report: ZIMMER GMBH MS-30®,STEM,STANDARD,CEMENTED,10, TAPER12/14; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Pain (1994); Unequal Limb Length (4534); Insufficient Information (4580)

Event Date 10/16/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a hip revision approximately 11 months post implantation due to unknown reasons.The surgeon is questioning changes found on the stem implant.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).D10: allofitâ® alloclassicâ®, shell with polar screw plug, uncemented, 56/kk item#4247 lot# unknonwn.Durasulâ®, alpha insert, kk/36 item#0100013711 lot# unknown unknown bilox delta head 36/m.G2.Foreign: switzerland.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a hip revision approximately 10 months post implantation due to developed pain with increased femoral lateralization and post-operative functional leg length difference.It was noticed there was fluid in the joint, deposits of unknown etiology were noted around zone 3 of the stem, and the leg length discrepancy was corrected.All implants were revised without complication.Diligence is complete and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported ms-30 stem was returned to the post market surveillance team for evaluation.A visual examination was performed and scratches throughout the stem, but primarily concentrated around the neck region, could be identified.Matt spots are present in the distal half of the stem.Additionally at the tip of the stem, several matt parallel horizontal lines, going around the stem could be identified.The aforementioned matt spots were further observed under the microscope with signs of fretting and corrosion being identified along with deposits of unknown origin.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.A review of the medical records revealed no intra-op complications or events during implantation.Approximately 7 months later patient had pain in left hip with increased femoral lateralization and functional leg length difference postoperatively and was aspirating a yellowish-clear liquid.Another aspiration was then done approximately 2 weeks later.The revision occurred approximately one month later with no noticeable accumulation of fluid in the joint, and synovitis was not particularly pronounced.Several radiographic images were received and reviewed by a radiologist and no signs of loosening, wear, radiolucency or any other contributing factor such as malalignment could be identified however, with the information provided, we are unable to provide further analysis of the complaint reported or draw any definitive conclusions as to the root cause of the reported issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information.

• Brand Name: MS-30®,STEM,STANDARD,CEMENTED,10, TAPER12/14
• 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: 18228739
• MDR Text Key: 329260130
• Report Number: 0009613350-2023-00656
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024592391
• UDI-Public: (01)00889024592391(10)271130(10)3132028
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 300049100
• Device Lot Number: 3132028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 12/20/2023; Not provided
• Supplement Dates FDA Received: 01/16/2024; 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 62 KG