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

Model Number	1570-12-090
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Necrosis (1971); Pain (1994); Discomfort (2330); No Code Available (3191)
Date of Event	09/30/2013
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
Patient was revised to address poly wear, and the liner was not fixed in the cup.Update 31 jul 2017: litigation received.Litigation alleges discomfort, pain, stiffness, loss of motion, metal toxicity, implant loosening, metallosis, necrosis, and soft tissue damage.Added the head for metallosis and stem for elevated metal ions.Added the complainant information.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Update sep 27, 2017: pfs and medical records received.After review of medical records for the mdr reportability, in addition to what was previously reported, revision notes reported implant noise, a large amount of black staining material, and gross soft tissue laxity.This complaint was updated on oct 18, 2017.
Additional Manufacturer Narrative
(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. .
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Ppf alleges constrained liner.Added lawyer, law firm and revision hospital.Added unknown hip implant due to previously alleged implant loosening.
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.H6 patient code: no code available (3191) was used to capture metal poisoning.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 SZ3 HI OFF
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6824977
• Report Number: 1818910-2017-23585
• Device Sequence Number: 682460
• Product Code: LPH
• UDI-Device Identifier: 10603295060147
• UDI-Public: 10603295060147
• 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: 2008
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/31/2017

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 Expiration Date: 09/01/2017
• Device Model Number: 1570-12-090
• Device Catalogue Number: 157012090
• Device Lot Number: B4KEJ1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 09/27/2017; 04/25/2018; 10/30/2018; 05/20/2020
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 10/20/2017; 05/07/2018; 11/06/2018; 05/21/2020
• 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: 66 YR
• Patient Weight: 91