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 Codes	Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Muscle Spasm(s) (1966); Pain (1994); Swelling (2091); Anxiety (2328); Discomfort (2330); Depression (2361); Joint Dislocation (2374); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	09/17/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Occupation: attorney.
Event or Problem Description
Litigation alleges the patient suffers from pain, discomfort, and dislocation.Even though the patient received a poly liner, the litigation is for metal on metal, so we are reporting the head and liner only.Update ad 03 may 2018 receipt of ppf and sticker sheets record.In addition to what were previously alleged, ppf alleges loosening of stem.
Event or Problem Description
Pfs alleges post traumatic stress disorder, depression, anxiety, insomia, spasm, cramps, swelling, muscle strain, limping, constipation, fear, panic attack, fall and implant dislocation.After review of medical records the patient was revised due to failed right hip acetabular revision resulting to pain.Operative note reported osteolysis, there was abundant synovial fluid clear and ambar.There were no infection and wear.Some oxidation and cavitary in the acetabulum and medialization of the cup.There was no loosening at the stem as per medical records the femoral component was solid.Year 2007 and 2008 patient suffered fall.
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 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: 8398555
• Report Number: 1818910-2019-86652
• Device Sequence Number: 297730
• 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: 2006
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2019

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 Model Number: 1570-12-090
• Device Catalogue Number: 157012090
• Device Lot Number: Z2NFW1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 07/16/2019; 04/08/2020
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 07/17/2019; 05/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 88