MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ3 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-12-090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Test Result (2695); No Code Available (3191)
Date of Event	08/21/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
Legal claim received alleging that the patient suffers from pain, stiffness, discomfort, and difficulty ambulating.Also alleged is excessive levels of chromium and cobalt.Update 09/25/2013- plaintiff¿s preliminary disclosure form was received, which identified dob and part/lot information.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.Update ad 19 may 2020; (b)(4) has been re-opened under (b)(4) due to receipt of medical records.After review of medical records patient was revised to addressed left hip pseudotumor, instability with metal on metal hip arthroplasty.Prior to revision patient alleged dislocation.Operative notes indicated synovitis within the acetabulum, chronic inflammation and fibrosis with pseudomembrane formation and metallosis.Added date of revision, account name, age of patient, gtin of cup and head, medical history and corrected date of birth.Also added stem and sleeve in impacted products.Doi: (b)(6) 2010 dor: (b)(6) 2020 left hip.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

• Brand Name: SUMMIT DUOFIX TAP SZ3 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: 10111652
• Report Number: 1818910-2020-13028
• Device Sequence Number: 3817454
• Product Code: LPH
• UDI-Device Identifier: 10603295060147
• UDI-Public: 10603295060147
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2013

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: No Information
• Device Model Number: 1570-12-090
• Device Catalogue Number: 157012090
• Device Lot Number: C3TCPA000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADAPTER SLEEVES 12/14 +8; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 46; SUMMIT DUOFIX TAP SZ3 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR