MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, LOCKING CAP; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: glenosphere eccentric 40 mm diameter +0 mm lateral offset; item#00436004025; lot#64464725; base plate uncemented 15 mm post length; item#00436201500; lot#64499689; poly liner plus 6 mm offset 40 mm diameter; item#00434904006; lot#64287432; ncb, cancellous screw¸ 4.5 mm, fully threaded, 40 mm; item#0203159040; lot#64413211; ncb, cancellous screw¸ 4.5 mm, fully threaded, 30 mm; item#0203159030; lot#64523530; therapy date: unknown.The manufacturer did not receive x-rays, or other source documents for review.The device history records were reviewed and found to be conforming.The manufacturer did not receive yet, the device, however it is indicated by complainant that it will be returned for investigation.Additional information has been requested and is currently not available.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
Patient underwent revision surgery due to broken screw and loose component.
Event or Problem Description
Investigation result is available now.
Additional Manufacturer Narrative
Event description: it was reported that there was a revision surgery due to broken screw and loose component.Review of received data: no medical data relevant to the case has been received.Product evaluation: visual examination: two screws have been returned for investigation.The visual examination shows that one screw is broken at the tip.The fractured piece has not been returned for evaluation.On the fracture surface, beach lines (progression marks) are visible which point to a fatigue fracture of the screw.The ratchet marks visible along the right side of the fracture surface indicate multiple fracture origins.The fracture surfaces shows also small polished areas.No other abnormality can be seen.Review of product documentation: device purpose: all involved devices are intended for treatment.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.Conclusion: it was reported that there was a revision surgery due to broken screw and loose component.The quality records show that all specified characteristics (material, dimensions, surface, etc.) for the screws have met the specifications valid at the time of production.Therefore, the investigation results did not identify a non-conformance or a complaint out of box (coob).The visual examination of the broken screw indicates a fatigue fracture.Macroscopically, no defects can be observed that could trigger or contribute to the fracture.Fatigue fractures can occur due to a cyclic overloading.It was also reported that the implants were loose.The received screws do not show any signs for screw loosening.There are also no x-rays received.However, based on the available information and performed investigation, an exact root cause for the screw breakage could not be determined and implant loosening cannot be confirmed.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: 0009613350-2020-00301-2, 0009613350-2020-00496-1, 0009613350-2020-00497-1.
Event or Problem Description
Patient was implanted on the unknown side and underwent revision surgery due to loosening and implant fracture.
Additional Manufacturer Narrative
Additional information which was received on oct 15, 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additionals: d7, d10.Corrections: b4, g4, g7, h10.The manufacturer did not receive any documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: NCB, LOCKING CAP
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10217267
• Report Number: 0009613350-2020-00300
• Device Sequence Number: 19474224
• Product Code: HRS
• UDI-Device Identifier: 00889024295926
• UDI-Public: 00889024295926
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 02.03150.300
• Device Lot Number: 4502568205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 10/15/2020; 12/18/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 10/23/2020; 12/24/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention