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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: item# 193206, lot# unknown, metasul, head, m, 32/0, taper 12/14.Item# 0100024552, lot# 2408920, fitmore, shell with screw cones, uncemented, 52/ii.Item# 0100010709, lot# 2436049, metasul, alpha insert, ii/32.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Device history record (dhr) was reviewed and no discrepancies were found.The following reports are associated with this event: 0009613350-2020-00165, 0009613350-2020-00167.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

It was reported that a patient underwent revision surgery approximately one year post implantation due to loosening and migration resulting a broken screw.Attempts to obtain additional information have been made; however, no more is available.

Event Description

Investigation has been completed.

Manufacturer Narrative

Investigation results were made available.Additional: h2, h6; correction: b4, b5, g4, g7, h10.Event description: it was reported that patient was implanted on (b)(6), 2009 and underwent revision on (b)(6), 2020 due to aseptic loosening and migration resulting in a broken screw.Review of received data: x-rays: one undated x-ray has been received.It can be seen that the cup is in a very steep position.As the x-ray is undated and presumably no post-operative image was received, no statements can be done about the changes in implant positioning and bone quality changes.No further analysis can be done.Images: images of the explanted products have been received.The state of the femoral head cannot be assessed, as it is only partially displayed in the background of the pictures.The bone anchoring side of the cup is not displayed, therefore no analysis of potential indications for loosening can be done.The inner surface of the cup has some tissue and blood residues.Moreover, there are several light scratches, which could have resulted from explantation.The inlay has some soft tissue attachment on the anchoring side to the cup.There is no picture of the broken screw.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all ininvolved devices are intended for treatment.-product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that patient was implanted on (b)(6), 2009 and underwent revision on (b)(6), 2020 due to aseptic loosening and migration resulting in a broken screw.Based on the investigation the reported event can be confirmed.The x-ray analysis confirmed the steep positioning of the cup.Moreover when comparing the center of rotation to the non-operated hip side, it can be assumed that the cup has migrated.Due to incomplete medical documentation, no analysis can be done concerning the sequence of events.The initial implantation angle of the cup remains unknown.The broken screw has neither been returned for an investigation, nor any pictures of the explant has been received.Therefore no further analysis can be performed.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 may be multifactorial an exact root cause could not be identified for the reported 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).The following reports are associated with this event: 0009613350-2020-00165-1, 0009613350-2020-00167-1.

• Brand Name: FITMORE, SHELL WITH SCREW CONES, UNCEMENTED, 52/II
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9920991
• MDR Text Key: 194160858
• Report Number: 0009613350-2020-00166
• Device Sequence Number: 1
• Product Code: LPH
• 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
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2012
• Device Model Number: N/A
• Device Catalogue Number: 01.00024.552
• Device Lot Number: 2408920
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2020
• 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