MAUDE Adverse Event Report: ZIMMER GMBH FITMORE SHELL WITH SCREW CONES, UNCEMENTED, 50/HH

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem No Information (3190)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: item# unknown, lot# unknown, fitmore cup hip implant.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 under 510(k) number k003758.Device evaluated by manufacturer: the device has not been received by manufacture; however, an attempt to obtain the information about availability of the device has been made.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The manufacturer did not receive x-rays, or other source documents for review.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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).Unknown product identification number.

Event Description

It was reported that the patient underwent revision surgery approximately 15 years post implantation due to cup loosening and partially broken surface coating.Attempts to obtain additional information have been made; however, no more has been provided at this time.

Manufacturer Narrative

Medical products: metasul, alpha insert, hh/28; part#0100010408; lot#2151646.Metasul head 28mm "m" 12/14 part#192806; lot#2165316.Cls spotorno stem, 135, uncemented, 7.0, taper 12/14 part#290039070; lot#2158980.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

It was reported that the patient underwent revision surgery approximately 15 years post implantation due to cup loosening and partially broken surface coating.Attempts to obtain additional information have been made; however, no more has been provided at this time.

Manufacturer Narrative

Investigation results were made available.Dhr review: ref#: 01.00024.550; lot#: 2123416.Yield: 49.Delivered: 49.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Trend analysis: no trend considering the following event is identified: medical : revision due to loosening.Event summary: revision of a fitmore-cup due to loosening: implantation of a cementless fitmore-cup with metal-metal slide pairing (metasul 28 mm) in 2003.Since 2017 increasing symptoms and radiological loosening of the cup and recognizable abrasion of the surface coating.Revision surgery was done on (b)(6) 2019 - removal of the completely loosened cup and the partially broken surface coating.Clear material failure due to regular implant placement during initial surgery (implantation).Review of received data: several x-rays from 2006 until 2019 were received and reviewed by an independent healthcare professional.Surgery report prof.(b)(6).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 and showed that the product combination was approved by zimmer biomet.Surgical technique: the correct implantation of the fitmore cup is described in the surgical technique.Conclusion summary: implantation of a cementless fitmore-cup with metal-metal slide pairing (metasul 28 mm) in 2003.Since 2017 increasing symptoms and radiological loosening of the cup and recognizable abrasion of the surface coating.Revision surgery was done on (b)(6) 2019 - removal of the completely loosened cup and the partially broken surface coating.Clear material failure due to regular implant placement during initial surgery (implantation).The fitmore cup was approx.16 years in vivo.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The received surgical report of the implantation dated (b)(6) 2003 do not show any abnormality.Several x-rays have been received and reviewed (by an independent healthcare professional): three years after the primary implantation, on 2006 radiological evidence of a missing secondary osseointegration of the cementless cup in the area of the acetabulum roof, additionally cup fixation by two screws.Unchanged situation with missing osseointegration of the cup on the acetabulum.Four years later on (b)(6) 2010 radiologically unchanged situation with missing osseointegration of the cup acetabulum roof and evidence of an incipient detachment of the sulmesh surface on the lower cup area and a suspected screw breakage.The complete detachment of the sulmesh surface fixed to the bony acetabulum on the lower part of the pelvis occurs radiologically with a clearly recognizable, dislocated fracture of a screw placed cranially in the os ilium and change of the cup inclination angle.The x-ray follow up 3 years after primary implantation shows a missing secondary osseointegration of the cup in the area of the acetabular roof and cup fixation by two screws, cementless implanted cup may have led to a detachment of the osseointegrated sulmesh surface on the lower of the acetabulum seven years after primary implantation.The further mechanical movement of the cup may have led to a dislocated breakage of a screw, to a steeper cup inclination angle and in the course complete detachment of the unchanged at the lower acetabulum fixed sulmesh surface.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the available information, an exact root cause could not be determined.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

Investigation results are now available.

• Brand Name: FITMORE SHELL WITH SCREW CONES, UNCEMENTED, 50/HH
• Type of Device: FITMORE SHELL WITH SCREW CONES
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8564852
• MDR Text Key: 143559611
• Report Number: 0009613350-2019-00275
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/15/2007
• Device Model Number: N/A
• Device Catalogue Number: 01.00024.550
• Device Lot Number: 2123416
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2019
• 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: 75 YR