MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL® DUROM®, COMPONENT FOR ACETABULUM, UNCEMENTED, 56/ø 50, CODE P; KNEE PROSTHESIS

Model Number N/A

Device Problems Peeled/Delaminated (1454); Loss of Osseointegration (2408)

Patient Problems Failure of Implant (1924); Pain (1994); Osteolysis (2377); Swelling/ Edema (4577)

Event Date 05/26/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: foreign - germany.D10: item name: metasulâ® ldhâ®, head, 50, code p, taper 18/20; item reference: 01.00181.500; item lot: 2307129.Item name: metasul ldh head adapter ¿m¿/0, taper 12/14-18/20; item reference: 01.00185.146; item lot: 2345877.Item name: original m.E.Müller®, stem, pt-10, straight, lateral, cemented, 15.0, taper 12/14; item reference: 12.00.39-150; item lot: 2296543.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00352, 0009613350-2023-00353, 0009613350-2023-00354.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 patient underwent revision of total hip implant due to pain, swelling and redness in the scar area.During the revision it was noted that the patient has a extraperitoneal infection with metal abrasion in the secretion.Other findings are: osteolysis, metal abrasion ring around the stem and detachment of titanium coating from acetabular cup.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.The following sections were updated: b4, b5, d2,, d9, g1, g3, g6, h1, h2, h3, h6, h10.No product was returned, however pictures of the stem and the cup were provided and assessed.Only the proximal part of the stem is visible.The stem is abraded in the are between the stem taper and the neck of the stem.Black tissue is visible in the surgical area of the hip.Only the outer part of the cup is visible.The coating of the cup is delaminated and most likely came off during removal of the cup from the acetabulum during revision surgery.Due to the low quality of the pictures a more in depth assessment is not possible.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment medical records were not provided.With the available information, 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.

• Brand Name: METASUL® DUROM®, COMPONENT FOR ACETABULUM, UNCEMENTED, 56/ø 50, CODE P
• Type of Device: KNEE 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: 17245711
• MDR Text Key: 318343027
• Report Number: 0009613350-2023-00355
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024422988
• UDI-Public: (01)00889024422988(17)110430(10)2325907
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 07/31/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2011
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.056
• Device Lot Number: 2325907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2006
• 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): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose