MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SOL SYS 8/15.0 SML ST; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Model Number	1572-01-150
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Distress (2329); Discomfort (2330); Injury (2348)
Date of Event	04/13/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Complaint description: new etq record created in order to update etq (legacy system) complaint number wpc (b)(4).Reason for original complaint - litigation alleges that patient has experienced metal ions being released into patient's blood, tissue, and bone surrounding the implant.As a result, patient experienced severe pain, discomfort, and inflammation in the thigh and groin.Patient has also experienced a popping and snapping sensation in the hip-joint when walking or moving to and from a sitting position.Update: 12/21/2012- patient fact sheet received.There is no new additional information that would affect the investigation.Records are available on the l:\drive if needed for further review.Update rec'd 12/21/2012- pfs and medical records received.Part/lot provided.A correct doi has been given.Original litigation mentioned issues from metal on metal; however, the sticker sheet indicates that the patient was actually implanted with poly.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 6/12/14.Update 4/29/15-pfs and medical records received.After review of the medical records for mdr reportability, there is no new additional information that would affect the existing mdr decision.The complaint was updated on:5/21/2015.
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.Udi: (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: SOL SYS 8/15.0 SML ST
• Common Device Name: SOLUTION STEM IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7337284
• Report Number: 1818910-2018-55023
• Device Sequence Number: 10812431
• Product Code: LPH
• UDI-Device Identifier: 10603295061359
• UDI-Public: 10603295061359
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K030979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/16/2018

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: No Information
• Device Model Number: 1572-01-150
• Device Catalogue Number: 157201150
• Device Lot Number: BY3BA1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 02/08/2019; 09/06/2019; 02/11/2021
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 02/18/2019; 07/15/2020; 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 99