MAUDE Adverse Event Report: ZIMMER GMBH SYNTHETIC TOP

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: biolox delta, ceramic femoral head, l 36/+3.5, taper 12/14; part#00877503603; lot#2980832.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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 or Problem Description
It was reported that during 2 stage hip revision surgery, the biolox delta head got damaged during impaction with synthetic top impactor.The damage happened because of small piece of metal into the impactor.The head and impactor were replaced with the new ones.The delay of 5 minutes was reported due to head removal.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Additional: d10, h2, h6.Correction: b4, g4, g7, h10.Investigation and conclusion - event review: it was reported that there was a mark on the biolox delta head after impaction with synthetic top impactor.The damage happened because of small piece of metal embedded in the impactor.- no further due diligence required as all required information to support the conclusion is available/was already requested.- no relevant medical data has been received.- visual examination: the impactor top as well as the biolox head were returned for an investigation.The impactor top has several signs of usage and deformation at the impaction area.The biolox head has metal transfer signs in the taper and a black scratch on the articular surface.No metal particle was found to be embedded in the impactor.- the product is intended for treatment.- the investigation results did not identify a non-conformance or a complaint out of box (coob).- it can be confirmed that the biolox head has a mark on the articulation surface.However, no metal particle was found embedded in the impactor, however, it cannot be excluded that it might have been removed during cleaning and desinfecting at the hospital or at zimmer biomet.In case of application of high forces, deformation at the impaction area can occur.A deterioration in function during use of the instrument is likely.It remains unknown what lead to the scratch on the biolox head.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 or Problem Description
No change to previously reported event.

• Brand Name: SYNTHETIC TOP
• Common Device Name: SYNTHETIC TOP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9486335
• Report Number: 0009613350-2019-00806
• Device Sequence Number: 19302089
• Product Code: HWA
• UDI-Device Identifier: 00889024303423
• UDI-Public: 00889024303423
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 78.00.38
• Device Lot Number: 4501581113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1