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

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bacterial Infection (1735); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign ¿ italy.Associated products: item number: unknown, item name: unknown cup, item lot: unknown.Item number: unknown, item name: unknown stem, item lot: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00048 and 0009613350-2023-00050.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.

Event Description

It was reported that the patient underwent revision of an unknown hip prosthesis due to an acute infection together with elevated levels of metal ions in the blood.Culture taken during surgery reveals the presence of streptococcus alactolyticus.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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Devices used for treatment.Complaint history review cannot be performed without product identification.According to legal allegations, the patient had a left total hip arthroplasty in 2007.During follow up over the course of 2016 to 2019, the patient experienced pain, lymphedema, elevated metal ions, and radiographic imaging displayed periacetabular osteolysis and a capsulated fluid collection.Subsequently, in (b)(6) 2020, the patient underwent stage i of a two stage revision.During the revision, the findings include of purulent drainage, complete absence of external rotators, pseudotumor, metal debris in the acetabulum, osteolysis of the acetabulum, cultures positive for streptococcus alactolyticus, and brownish material surrounding the head, neck, and stem.Of note, the documentation provided was scanned only every second page; therefore, due to missing pages in the documentation, the reconstructed timeline might be incomplete.In addition, the medical records confirming these allegations have not been received.No corrective actions, preventive actions, or field actions resulted after investigation of this 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.

Event Description

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

• Brand Name: UNKNOWN HEAD
• 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: 16350391
• MDR Text Key: 309260969
• Report Number: 0009613350-2023-00049
• Device Sequence Number: 1
• Product Code: JDI
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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 Model Number: N/A
• Device Catalogue Number: UNKOWN HEAD
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/21/2023
• 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.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female