MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 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 Codes	Pain (1994); Not Applicable (3189)
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 named (b)(6) is female, (b)(6) years old and (b)(6), accepted tha on (b)(6) 2012.No anomalies were occurred in procedure.The hip of patient felt pain and returned hospital on (b)(6) 2018.X-ray report indicated implant broke.The broken device will be exchanged in revision surgery on (b)(6) 2018.The patient is under monitoring at hospital.Doi: (b)(6) 2012; dor: planned on (b)(6) 2018; unknown hip.
Additional Manufacturer Narrative
(b)(4).Investigation summary no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.Device history lot 178098 device history review reviewed dhr and material certs.No anomalies or discrepancies were found.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 12.0 MMA 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: 7475126
• Report Number: 1818910-2018-58550
• Device Sequence Number: 1976514
• 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: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2018

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: Health Professional
• Device Catalogue Number: 157153000
• Device Lot Number: 178098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Initial Date Received by Manufacturer: 04/08/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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: 64 YR
• Patient Weight: 70