MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SOL SYS 8/10.5 SML ST; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Catalog Number	157112000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Event: after performing the hip revision to the patient, the patient related that he felt when the bone made a noise, it was when the specialist performed an x-ray and it was verified that the stem was cracked.The day after having taken the exam, the patient felt another noise in his hip and it was when he completely fractured the rod solution.Product code: (b)(4).Lot not informed.Procedure: hip surgery.Patient consequence? :yes.Patient consequence description: perform bone osteotomy to remove the prosthesis.Action taken for procedure: change of surgical approach.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SOL SYS 8/10.5 SML ST
• 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: 7613281
• Report Number: 1818910-2018-62534
• Device Sequence Number: 1946309
• Product Code: LPH
• UDI-Device Identifier: 10603295061328
• UDI-Public: 10603295061328
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K953703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 157112000
• Device Lot Number: 369299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 05/27/2018
• Supplement Date Received by Manufacturer: 08/09/2018; 10/16/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 08/10/2018; 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 83