MAUDE Adverse Event Report: ZIMMER GMBH FITMORE, HIP STEM, UNCEMENTED, OFFSET B (EXTENDED)/6, TAPER 12/14; ZIMMER POROLOCK MIS STEM

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive devices for review.One x-ray picture and operative picture were received and will be reviewed within the investigation.Where lot numbers were received for the device, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Additional information has been requested and is currently not available.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).
Event or Problem Description
It was reported that patient underwent revision surgery due to pain and aseptic loosening.
Event or Problem Description
No event update.
Additional Manufacturer Narrative
Investigation results were made available.Dhr review: ref#: (b)(4).Lot#: 2708605 - yield: 70 - delivered: 67 - scrapped: 3 following ncr were found: -3 parts scrapped due to damaged cone the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: stem loosening.No lot trigger: no similar investigated events for the same lot number 2708605 have been found.Review of event description: - it was reported that the patient had a revision surgery on (b)(6) 2019 due to pain.The diagnostic was aseptic loosening of the fitmore stem.Review of received data statement from an healthcare professional: x-ray picture, left hip ap-view (planning sketch) undated: situation after inserted cementless endoprosthesis stem on the left side with a planning sketch.Additional undamaged cerclage wires above and below the lesser trochanter.Laterally recognizable sclerosis line, medially with a significant distance from the lateral edge of the prosthesis.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.Compatibility: as the ref and lot of the other components are unknown a compatibility check could not be done.Instruction for use (ifu): early or late loosening of components is mentioned under the section adverse effects.Conclusion summary : it was reported that the patient was revised on (b)(6) 2019 due to pain.The diagnostic was aseptic loosening of the fitmore stem.The implantation date is unknown.Radiologically, a significant radiolucent line laterally of the stem is seen as a possible indication of stem loosening.Due to the recognizable undamaged cerclage wires in the anchoring area of the prosthesis, it can be assumed that a fracture may have occurred intraoperatively during the primary implantation.Whether a periprosthetic fracture situation in the intertrochanteric metaphyseal anchorage area of the prosthesis stem could have played a role in the cause of the reported loosening of the stem cannot be medically assessed from the available documentation.The investigation results did not identify a non-conformance or a complaint out of box (coob).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).

• Brand Name: FITMORE, HIP STEM, UNCEMENTED, OFFSET B (EXTENDED)/6, TAPER 12/14
• Common Device Name: ZIMMER POROLOCK MIS STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8342433
• Report Number: 0009613350-2019-00075
• Device Sequence Number: 11241590
• Product Code: KWA
• UDI-Device Identifier: 00889024482906
• UDI-Public: 00889024482906
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K071723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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 Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.00551.306
• Device Lot Number: 2708605
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 09/30/2019
• 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
• Patient Weight: 80