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

Catalog Number	157208136
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	05/17/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Initial reporter occupation: lawyer.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
Sticker sheets received via cd shipment.There are no allegations reported.Sticker sheets indicate that the patient had undergone a revision of acetabular cup and head.However, reason for revision was not provided.If/when more information is received, this complaint will be updated accordingly.Cup was previously reported on (b)(4).Doi: (b)(6) 2009; dor: (b)(6) 2011 (right hip).

• Brand Name: SOL SYS 8/13.5 R BOW
• 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: 9349277
• Report Number: 1818910-2019-117237
• Device Sequence Number: 297667
• Product Code: LPH
• UDI-Device Identifier: 10603295061571
• UDI-Public: 10603295061571
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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: D6EGW1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/20/2019
• 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
• Patient Age: 56 YR