MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54/ 48, CODE N; DUROM ACETABULAR COMPONENT

Model Number N/A

Device Problems Collapse (1099); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: metasul durom, component for femur, cemented, 48/n; catalog#: 01.00211.148; lot#: 2309216.Therapy date: (b)(6) 2020.The manufacturer received x-rays for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.Based on an extensive investigation of events reported from several user facilities outside the usa, zimmer identified that the most probable cause for the outcome observed was a loose or unstable cup that resulted from use of surgical techniques not consistent with the manufacturer's recommendations.As a corrective action, a retraining program for users outside the usa was initiated in november 2009 and reported to the national competent authorities as required.The durom cup reported in this case is not marketed in the usa.A similar cup, compatible with the metasul ldh femoral head, is cleared in the usa and a corrective action for this product was reported to the fda in july 2008 as notification z-2415/2426-2008.Since this case is related to the issues for which zimmer implemented a corrective action there will be no further investigation.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the right side and underwent revision surgery due to loosening of implant and femoral head collapse.The surgery was delayed by 45 minutes as the surgeon had to remove the porous coating that remained in the acetabulum.

Manufacturer Narrative

This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.This case was reopened on apr 23, 2021 to enter additional information which had been received on apr 21, 2021.Since this case is related to the issues for which zimmer implemented a corrective action which was reported to the fda in july 2008 as correction z-2415/2426-2008, there will be no further investigation and zimmer gmbh will close this case once again.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the right side and underwent revision surgery due to loosening of implant and femoral head collapse.The surgery was delayed by 45 minutes as the surgeon had to remove the porous coating that remained in the acetabulum.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6 correction: b4, g3, g6, h10.Event description: it was reported that the patient was implanted on (b)(6), 2007 and underwent revision surgery after 13 years 9 months in vivo on (b)(6), 2020 due to loosening of implant and femoral head collapse.The revision surgery was delayed by 45 minutes since the surgeon needed to remove the porous coating that remained in the acetabulum.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.X-rays: two undated x-rays of the right hip in two differnt views were received for investigation.On both x-rays the collapse femoral head and neck thinning / necrosis can be observed.As a complete x-ray followup is not avaialble, changes to the bone over time cannot be assessed.Images: one intraoperative picture was received which shows the situation when the cup was removed.On the picture it is visible that the coating is missing on the backside of the cup.When looking into the hip joint it is also observable that the porous coating is still in the acetabulum.Product evaluation: visual examination: the durom femoral component shows slight damage from the revision surgery,(b)(6) and coarse scratches.On the anchoring side, the remains of the cement mantle are still inside the femoral component.The cement mantle is irregular with a thickness less than 1 mm.The cement shows slight spongy structure, possible remains of bone and slight polishing.On the outer surface of the slim stem small polished areas can be observed.On the articulating surface of the femoral component slight scratches can be seen.The durom cup shows numerous fine scratches on the articulation side.The coating on the anchoring side is completely missing.The backside of the cup is polished.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr / ncr review: review of the device history records identified no deviations or anomalies during manufacturing.Review of the device history records identified that 2 parts scrapped due to dimension deviation.The ncr and dhr review showed that all released products met the specifications valid at the time of production.Conclusion: it was reported that the patient was implanted on (b)(6) 2007 and underwent revision surgery after 13 years 9 months in vivo on (b)(6) 2020 due to loosening of implant and femoral head collapse.The revision surgery was delayed by 45 minutes since the surgeon needed to remove the porous coating that remained in the acetabulum.The review of the x-rays revealed that the femoral head collapsed.This corresponds with the slight polishing found on the durom femoral component.The coating of the durom cup is completely missing and the backside of the cup is polished.As reported and shown in a received picture, when removing the cup, the coating remained in the acetabulum.Based on the investigation the reported event can be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).In conclusion, as the cause for the collapsed femoral had may be multifactorial which contributing factors from the patient, surgery and device.Therefore, an exact root cause could not be identified for the reported event.Based on the available information it remains unknown if the porous coating detached in vivo or during the revision surgery.It can only be assumed that the coating was well anchored into the bone.Based on the investigation it remains unknown why it came to the detachment of the coating.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).

Event Description

No change to previously reported event.

• Brand Name: METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54/ 48, CODE N
• Type of Device: DUROM ACETABULAR COMPONENT
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10850517
• MDR Text Key: 216597617
• Report Number: 0009613350-2020-00538
• Device Sequence Number: 1
• Product Code: KWA
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2011
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.054
• Device Lot Number: 2345976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2021
• 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
• Patient Age: 56 YR