MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL® LDH®, HEAD ADAPTER, M, 0, TAPER 12/14-18/20; DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

Model Number N/A

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530)

Event Date 01/29/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent initial right total hip arthroplasty.Subsequently revised due to pain and elevated metal ions.During the procedure metallosis, pseudotumor, bone erosion, scar tissue, soft tissue damage and trunnionosis was encountered.The head was exchanged without complications.The stem and acetabular components remained intact.

Manufacturer Narrative

Medical product: metasul® ldh®, head, 48, code n, taper 18/20 catalog#: 01.00181.480; lot#: 2437780 zimmer mmc, cup, uncemented, 58 mm/50 mm, code p catalog#: 01.00634.058 ; lot#: 2519529 femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 11 extended offset catalog#: 00-7711-011-20 ; lot#: 61365648 due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer gmbh winterthur legal department is well trained and passes all information concerning the case to our complaint handling department.As soon as supplemental information becomes available an updated report will be submitted.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00058; 0009613350-2022-00060.

Event Description

No event update.Investigation results are now available.

Manufacturer Narrative

As no product was returned, visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.No further due diligence required as all required information to support the conclusion is available or was already requested.Devices are used for treatment.The product combination was approved by zimmer biomet.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination related to the event.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient underwent hip surgery in (b)(6) 2010.The patient then had i&d for unknown reason in (b)(6) 2017.The patient was revised in (b)(6) 2020 due to pain and elevated ions.The patient had dull ache and elevated cobalt and chromium ion levels.Previous incision utilized and encountered inflammatory fluid and pseudotumor was removed.The scar tissue was removed and metallosis and soft tissue destruction was encountered.Trunnionosis/corrosion present once head removed and the trunnion was cleaned.Bone erosion at proximal femur at bone implant interface.Femur and acetabular components stable and remained intact.The investigation did not identify a nonconformance or a complaint out of box (coob).A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: METASUL® LDH®, HEAD ADAPTER, M, 0, TAPER 12/14-18/20
• Type of Device: DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
• 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: 13449366
• MDR Text Key: 285236325
• Report Number: 0009613350-2022-00059
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 01.00185.146
• Device Lot Number: 2482725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male