MAUDE Adverse Event Report: ZIMMER GMBH FITMORE STEM

Model Number N/A

Device Problem Migration (4003)

Patient Problems Memory Loss/Impairment (1958); Pain (1994)

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

Medical product.36mm cocr head; catalog no#: unknown; lot#: unknown.Continuum shell; catalog no#: unknown; lot#: unknown.Longevity liner;catalog no#: unknown; lot#: unknown.Therapy date: (b)(6) 2016.The manufacturer did not receive x-rays 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.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).

Event Description

Patient was implanted on the right side and underwent revision surgery due to pain, failure to ossetointergrate, subsidence, elevated metal ions, loosening, memory loss.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient underwent revision on (b)(6) 2016 due to pain, failure to osseointegrate, subsidence, elevated metal ions, loosening, and memory loss following primary right tha on (b)(6) 2014 with implantation of a fitmore stem.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Maude report: patient received a right total hip arthroplasty via the anterior approach with zimmer fitmore stem with a 36mm cocr head, continuum shell and longevity liner.His right hip pain began in 2014 after doing physical therapy to rehabilitate the hip.He recalls that the pain was notable when carrying a heavy cooler.X-ray of the hips made in 2019 showed that the right femoral stem was not osseointegrated and had settled 1.3 cm suggestive of fibrous fixation.In 2016 the serum / plasma cobalt level was 1.5 mcg/l.In addition, he has noted new onset of fatigue, peripheral neuropathy, disordered mood and some new memory issues.On (b)(6) 2016, the right tha was revised due to fibrous fixation aseptic loosening of the right femoral stem and elevated cobalt levels.The right hip was revised to a wagner sl revision stem.There was moderate capsular thickness and fluid in the joint that was under some degree of pressure.The fitmore stem was loose and subsided and extracted without difficulty.Following revision of the right hip, his blood cobalt level was now 0.6 mcg/l and his urine cobalt level was 0.8 mcg/l.Medical records: except of the maude report, no medical records have been received.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed due to missing product identification.Conclusion: it was reported that the patient underwent revision on (b)(6) 2016 due to pain, failure to osseointegrate, subsidence, elevated metal ions, loosening, and memory loss following primary right tha on (b)(6) 2014 with implantation of a fitmore stem.Neither x-rays, operative notes, office visit notes, nor device or photos of the device were received; therefore, the condition of the component is unknown.Patient factors that may have affected the performance of the components such as bone quality, activity level, type of activity low impact vs.High impact, and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.Therefore, based on the lack of medical records the reported event cannot be confirmed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a non-conformance or complaint out of box.Based on the given information and the results of the investigation, we were not able to identify a specific 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 STEM
• Type of Device: FITMORE STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9897430
• MDR Text Key: 194014486
• Report Number: 0009613350-2020-00155
• Device Sequence Number: 1
• Product Code: LZO
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention