MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH FITMORE SHELL WITH SCREW CONES, UNCEMENTED, 52/II

Model Number N/A

Device Problems Material Erosion (1214); Naturally Worn (2988); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002); Component Misassembled (4004)

Patient Problems Failure of Implant (1924); Osteolysis (2377); Reaction (2414)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products and therapy date detail of products: item # unknown, item name metasul insert, lot # unknown.Item # unknown, item name metasul head, lot # unknown.Item # unknown, item name stem versys et # 14, lot # unknown.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.Attempts to obtain additional information have been made; however, no more is available.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.(b)(4).

Event Description

A patient is pursuing a product liability claim because underwent revision surgery (exact date unknown, (b)(6) 2018) due to onset of cold symptoms, squeaking sound, metallosis, loosening with wear (cup), disassembly of the metasul insert, periprosthetic osteolysis with bone deficiency and elevated metal ion levels.

Manufacturer Narrative

Medical products: metasul insert ii/28 ref.4345, lot 2132355.Metasul head 28mm s 12/14 ref.19.28.05, lot 2111856.Femoral stem press-fit enhanced taper 12/14 neck taper collarless size 14 135 mm stem.Length cementless ref.00-7861-014-04, lot 60300110.Additional information which was received on dec 4, 2019.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the right side and underwent revision due to squeaking sound, metallosis, wear, loosening, osteolysis and elevated metal ion level.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event summary: it was reported that on (b)(6) 2005 the patient was admitted to hospital and diagnosed with coxarthrosis on the right.Subsequently, on (b)(6) 2005 the products (fitmore cup 52mm, versys et stem 14, metasul insert and head) were implanted and revised in (b)(6) 2018 due to onset of cold symptoms, squeaking sound, metallosis, loosening with wear (cup), disassembly of the metasul insert, periprosthetic osteolysis with bone deficiency and elevated metal ion levels.Patient has suffered significant biological, psychological (anxiety disorder) and financial damages.Review of received data: no further due diligence required as all required information to support the conclusion is available/was already requested.No medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all involved devices are intended for treatment.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Conclusion summary : it was reported that on (b)(6) 2005 the patient was admitted to hospital and diagnosed with coxarthrosis on the right.Subsequently, on (b)(6) 2005 the products (fitmore cup 52mm, versys et stem 14, metasul insert and head) were implanted and revised in (b)(6) 2018 due to onset of cold symptoms, squeaking sound, metallosis, loosening with wear (cup), disassembly of the metasul insert, periprosthetic osteolysis with bone deficiency and elevated metal ion levels.Patient has suffered significant biological, psychological (anxiety disorder) and financial damages.In vivo time of the device is 13 years.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the available information, we were not able to identify an exact root cause for this issue.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

Manufacturer Narrative

Additional information which was received on (b)(6) 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additionals: a4, b3, b5, b6, b7, d7, g7, h1, h2, h10.Corrections: b4, g4.The manufacturer received other source documents for review.Should any additional information become available or an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the right side and underwent revision due to squeaking sound, metallosis, wear, loosening, osteolysis and elevated metal ion level.

Manufacturer Narrative

Event summary: it was reported that on (b)(6) 2005 the patient was admitted to hospital and diagnosed with coxarthrosis on the right.Subsequently, on (b)(6) 2005 the products (fitmore cup 52mm, versys et stem 14, metasul insert and head) were implanted and revised in (b)(6) 2018 due to onset of cold symptoms, squeaking sound, metallosis, loosening with wear (cup), disassembly of the metasul insert, periprosthetic osteolysis with bone deficiency and elevated metal ion levels.Patient has suffered significant biological, psychological (anxiety disorder) and financial damages.Review of received data no further due diligence required as all required information to support the conclusion is available/was already requested.X- ray reports: post-operative control shows results of bicompartmental endoprosthesis coxo-right femoral regularly allocated and inserted, non cemented type, without signs of peri-prosthetic bone discontinuity or mobilization.Surgical drains are present.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all involved devices are intended for treatment.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Conclusion summary: it was reported that on (b)(6) 2005 the patient was admitted to hospital and diagnosed with coxarthrosis on the right.Subsequently, on (b)(6) 2005 the products (fitmore cup 52mm, versys et stem 14, metasul insert and head) were implanted and revised in (b)(6) 2018 due to onset of cold symptoms, squeaking sound, metallosis, loosening with wear (cup), disassembly of the metasul insert, periprosthetic osteolysis with bone deficiency and elevated metal ion levels.Patient has suffered significant biological, psychological (anxiety disorder) and financial damages.In vivo time of the device is 13 years.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the available information, we were not able to identify an exact root cause for this issue.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: FITMORE SHELL WITH SCREW CONES, UNCEMENTED, 52/II
• Type of Device: FITMORE SHELL WITH SCREW CONES
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9304132
• MDR Text Key: 166603640
• Report Number: 0009613350-2019-00668
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2009
• Device Model Number: N/A
• Device Catalogue Number: 01.00024.552
• Device Lot Number: 2230554
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: REFER TO H10.; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 90