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

Catalog Number	157153000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/01/2018
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
Implant breakage.The patient accepted left tha on (b)(6) 2013.No anomaly was observed.The patient felt pain and returned hospital on (b)(6) 2018.X-ray report indicated solution stem broke.Revision surgery will be done.Now patient is at hospital for monitoring.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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).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
The patient accepted revision surgery on (b)(6) 2018.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: (b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.If information is obtained that was not available for the initial 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 US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7615639
• Report Number: 1818910-2018-62609
• Device Sequence Number: 2292449
• Product Code: LPH
• UDI-Device Identifier: 10603295061069
• UDI-Public: 10603295061069
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K953703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 157153000
• Device Lot Number: 221349B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 06/27/2018; 08/03/2018; 08/27/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 07/02/2018; 08/10/2018; 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR