MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SOL 10.5 STD 8.0 FULL PC 12/14; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Catalog Number	157112000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)
Date of Event	08/05/2017
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
Complaint received through our legal department.Revision due to pain and inflammation.
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
In addition to what was previously alleged, claimant is now stated to have experienced loss of mobility.
Additional Manufacturer Narrative
(b)(4).No device was returned, however a photo was received and confirmed the stem had fractured.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.

• Brand Name: SOL 10.5 STD 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: 8147147
• Report Number: 1818910-2018-77677
• Device Sequence Number: 1225451
• Product Code: LPH
• UDI-Device Identifier: 10603295060734
• UDI-Public: 10603295060734
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K953703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2018

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: 168224
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 01/15/2019; 02/07/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 01/22/2019; 02/07/2019
• 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