MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SOL 12.0 MMA 8.0 FULL PC 12/14; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Model Number	1571-53-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Hip Fracture (2349); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Surgeon reported ae to bfarm: patient came to hospital with strong pain.No trauma.X-ray showed a stem fracture.Revision with change of inlay and stem with fracture-osteosynthesis on (b)(6) 2019.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
On 17-jul-2019 surgeon sent x-rays to (b)(6) plus some medical info: periprosthetic fracture right; change to solution with cablecerclage osteosynthesis; trochanteric fracture ; osteosynthesis with trochanteric plate; prostheses stem breakage ; change to prevision stem.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
Clinical info: about 3 weeks ago pressure and strain pain in the area of the left thigh.Patient is permanent physiotherapeutic treatment because of parkinson disease.The physiotherapist noticed the increasing movement restriction and caused control.Before this patient was mobile without aids.Currently (*) significant increase in complaints with intermittent immobility.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : addendum added (b)(6) 2020.Following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be closed with an unjustified conclusion, it shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.No device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SOL 12.0 MMA 8.0 FULL PC 12/14
• Common Device Name: SOLUTION STEM IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8736985
• Report Number: 1818910-2019-96903
• Device Sequence Number: 2573029
• Product Code: LPH
• UDI-Device Identifier: 10603295061069
• UDI-Public: 10603295061069
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/17/2019

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: Health Professional
• Device Model Number: 1571-53-000
• Device Catalogue Number: 157153000
• Device Lot Number: A71FL1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 07/15/2019; 07/18/2019; 08/06/2019; 10/16/2019; 02/07/2020
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/17/2019; 07/19/2019; 08/07/2019; 10/17/2019; 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUR MAR 10D LNR 32IDX56OD; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP IMPLANT-SCREW; UNKNOWN HIP IMPLANT-SCREW; UNKNOWN HIP IMPLANT-SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 37