MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN CUP; HIP PROSTHESIS

Model Number N/A

Device Problems Peeled/Delaminated (1454); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 05/05/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 ¿ cocr head 28/-4 s 12/14, item#: 14.28.05-20, lot# 2296988.Unknown liner, item#: unknown, lot# unknown.G2 ¿ foreign ¿ italy.H3 ¿ other: part# and lot# unknown.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.H3 other text : see h10 narrative.

Event Description

It was reported that the patient underwent a total right hip arthroplasty, and subsequently, approximately twenty years post implantation, the cup, head and liner were revised due to cup loosening and delamination of the porous coating.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

It was reported that the patient underwent a total hip arthroplasty, and subsequently, approximately twenty years post implantation, the cup, head and liner were revised due to cup loosening and worsening pain.During the revision it was noted that a large area without porous relining was found which remained adhered to the bony surface of the cup.The femoral component appears solid and integrated with the femur.Head, acetabular cup, and liner were explanted without complications.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records could not be performed due to missing lot number.A review of the complaint history could not be performed due to missing reference and lot numbers.With the available information a definitive root cause cannot be established.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.H3 other text: no product information or return.

Event Description

Diligence is complete and to date no additional information on the reported event have been received.

• Brand Name: UNKNOWN CUP
• 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: 17947621
• MDR Text Key: 325798478
• Report Number: 0009613350-2023-00589
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• 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 CUP
• 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: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 80 KG