MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SOL SYS 8/13.5 R BOW; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Catalog Number	157208136
Medical Device Problem Codes	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/23/2018
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
Revised due to a break in the stem.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Examination of the x-ray image provided confirmed the reported event.A worldwide complaint database search found no other related reported incident(s) against the provided product/lot combination(s) since release for distribution.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.Device history lot: ae3lx1000.Device history review: there was a nonconformance and hold ticket associated with this batch for the incorrect placement of a sticker.The disposition of the nonconformance was use as is.No other deviations or anomalies were observed.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 SYS 8/13.5 R BOW
• 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: 8069509
• Report Number: 1818910-2018-75420
• Device Sequence Number: 16503707
• Product Code: LPH
• UDI-Device Identifier: 10603295061571
• UDI-Public: 10603295061571
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K060581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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: 157208136
• Device Lot Number: AE3LX1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/18/2018
• 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: 65 YR