MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ5 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-12-110
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Osteolysis (2377); Test Result (2695); No Code Available (3191)
Date of Event	03/20/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.(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
Reason for original complaint-litigation papers allege the patient has experienced pain and discomfort in his hip since the asr hip was implanted.As a result, a revision surgery was performed to replace the asr system implanted in his left hip.The patient continues to experience pain in his left hip and has suffered from injuries of a permanent, lasting and painful nature.After review of medical records, the patient was revised to address discomfort.Mri showed a large, complex, fluid-filled cyst within the capsule as well as osteolysis within the pubis and elevated ion levels.Intraoperative findings noted about 40 ml of yellow fluid, a lot of corrosion around the taper and a small bit of particulate disease that went up inside the psoas tendon sheath.Lab results were not provided for the alleged elevation of ion levels.Doi: (b)(6) 2007; dor: (b)(6) 2012; (left hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
Medical record received.It was stated that the patient has very mild lysis.There is mild heterotopic formation of bone.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT DUOFIX TAP SZ5 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8837286
• Report Number: 1818910-2019-99561
• Device Sequence Number: 2742561
• Product Code: LPH
• UDI-Device Identifier: 10603295060161
• UDI-Public: 10603295060161
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1570-12-110
• Device Catalogue Number: 157012110
• Device Lot Number: BK8EB1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 11/26/2019; 04/08/2020
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 12/19/2019; 04/21/2020
• 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: 63 YR