MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL®, ALPHA INSERT, II/32; HIP PROSTHESIS

Model Number N/A

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

Patient Problems Ossification (1428); Unspecified Infection (1930); Pain (1994); Metal Related Pathology (4530)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Metasulâ®, head, s, 㸠32/-4, taper 12/14, item# 193205, lot# 2595879 fitmoreâ®, shell with screw cones, uncemented, 52/ii, item# 01.00024.552, lot# 2658452 femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 11 extended offset, item# 65771101120, lot# 61915179.Report source: foreign ¿ australia.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00034.0009613350-2023-00035.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 multiple left hip procedures due to infection and metallosis.Approximately 8 years post implantation the patient underwent a revision with a cement spacer implanted and subsequently, a second stage revision approximately 3 months later.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(6) this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: a1, a2, b4, b5, d2, d9, g3, g6, h1, h2, h3, h6, h10.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 : device location unknown.

Event Description

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.The following sections were updated: b4, b5, b7, d2, d9, g1, g3, g6, h1, h2, h3, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.The devices are used for treatment.Medical records were provided and reviewed by a health care professional.A review of the available records identified tissue debridement with extensive washout and ossification noted around the joint.A definitive root cause cannot be determined.

• Brand Name: METASUL®, ALPHA INSERT, II/32
• 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: 16302616
• MDR Text Key: 308823856
• Report Number: 0009613350-2023-00036
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024432062
• UDI-Public: (01)00889024432062(17)160731(10)2622158
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 01.00010.709
• Device Lot Number: 2622158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2011
• 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.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male