MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT DUOFIX TAP SZ6 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157012120
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Erosion (1750); Inflammation (1932); Pain (1994); Swelling (2091); Tissue Damage (2104); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Date of Event	04/09/2013
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.Device was used for treatment, not diagnosis.Initial reporter occupation: non-healthcare professional "attorney".(b)(4).
Event or Problem Description
Litigation papers allege that the patient has suffered pain, swelling, lack of mobility, damage to surrounding tissue and bone caused by inflammation, metallosis, pseudotumors, bursitis, and bone erosion.Update the patient's right hip was revised on (b)(6) 2013 to address pain/discomfort.Update in addition to what were previously alleged, ppf alleges elevated metal ions.Doi: (b)(6) 2005 - dor: b)(6) 2013 (right hip).
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.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.

• Brand Name: SUMMIT DUOFIX TAP SZ6 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 8590865
• Report Number: 1818910-2019-92805
• Device Sequence Number: 2293427
• Product Code: LPH
• UDI-Device Identifier: 10603295060178
• UDI-Public: 10603295060178
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2012

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: 157012120
• Device Lot Number: ZP5C31000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 11/06/2019
• 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: 55 YR
• Patient Weight: 88