MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH FITMORE, HIP STEM, UNCEMENTED, OFFSET B (EXTENDED)/5, TAPER 12/14; ZIMMER POROLOCK MIS STEM

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: medical reports: biolox delta, ceramic femoral head, m, 32/0, taper 12/14; catalog#: 00-8775-032-02; lot#: 2729885.Oblique liner 36 mm i.D.Size ii for use with 52 mm o.D.Size ii shell; catalog#: 00-8755-010-36; lot#: 64030590.Elevated rim liner 32 mm i.D.Size ii for use with 52 mm o.D.Size ii shell; catalog#: 00-8852-010-32; lot#: 63028929.Shell with cluster holes porous 52 mm o.D.Size ii for use with ii liners catalog#: 00-8757-052-01; lot#: 63007015.Bone screw self-tapping 6.5 mm dia.40 mm length; catalog#: 00-6250-065-40; lot#: 63116707.Bone screw self-tapping 6.5 mm dia.15 mm length; catalog#: 00-6250-065-15; lot#: 63069079.Therapy date: (b)(6) 2021.The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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 or Problem Description
Patient was implanted on the right side and was operated on (b)(6) 2021 to correct the periprosthetic fracture during which the poly liner was revised.Any kind of trauma has not been reported.
Additional Manufacturer Narrative
Investigation results were made available.1.Event description: it was reported that the patient was implanted on (b)(6) 2015.Subsequently, the patient fell and sustained a femoral periprosthetic fracture and underwent revision surgery on (b)(6) 2021.Harm: s3 - bone fracture hazardous situation: patient's anatomy is exposed to excessive external forces postoperatively.2.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: radiographic analysis was performed by a radiologist.Ap pelvis and single view of the right hip demonstrates a right total hip arthroplasty with screw fixation of the acetabular cup.Oblique fracture involving the proximal femoral diaphysis which involves the femoral stem component.The right acetabular inclination angle is around 45°.There are no signs of loosening, wear, and radiolucency.No anatomical contributing factors are present.No additional relevant medical data is available.3.Product evaluation: devices are not returned due to hospital policy.4.Review of product documentation: device purpose: all involved 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.5.Conclusion: it was reported that the patient was implanted on (b)(6) 2015.Subsequently, the patient fell and sustained a femoral periprosthetic fracture and underwent revision surgery on (b)(6) 2021.Radiographic analysis confirmed the reported periprosthetic femur fracture.No anatomical or device-related factors were found that could have contributed to the event.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).Based on the event description, the most likely cause of the periprosthetic fracture is the patient's fall.However, based on the information given, no exact cause can be identified with certainty.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 (b)(4).The following reports are associated with this event: 0009613350-2021-00430-1.
Event or Problem Description
Investigation results are now available.

• Brand Name: FITMORE, HIP STEM, UNCEMENTED, OFFSET B (EXTENDED)/5, TAPER 12/14
• Common Device Name: ZIMMER POROLOCK MIS STEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 12358531
• Report Number: 0009613350-2021-00425
• Device Sequence Number: 17096928
• Product Code: KWA
• UDI-Device Identifier: 00889024591684
• UDI-Public: 00889024591684
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K071723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 01.00551.305
• Device Lot Number: 2772971
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 10/22/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 59 YR