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

Model Number	1570-13-090
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)
Date of Event	10/29/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter 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
Pfs and medical records received.Medical records show the patient was revised again on (b)(6) 2013 for a failed liner.After reviewing the operative note it showed the patient had a broken lip of the liner and a malpositioned cup.A acetabular cup and unknown liner are being reported.(b)(4) is a reopen of (b)(4) due to receipt of new information.Update 13 apr 2018.Pinnacle pfs, ppf and medical records received.In addition to what was previously alleged, pfs alleges pain and difficulty of walking.Ppf alleges of loosening of the cup.After review of medical records for mdr reportability, operative reported dated (b)(6) 2013 that there is a plastic debris where the lip of the constrained liner had broken.It was also reported that the head and locking ring was removed.But there was no reported in the operative report that the cup was loosed.
Additional Manufacturer Narrative
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.H6 patient code: no code available (3191) was used to capture femur fracture.

• Brand Name: SUMMIT CEMENTED STEM SZ3 HI
• 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: 9070618
• Report Number: 1818910-2019-104646
• Device Sequence Number: 11540306
• Product Code: JDI
• UDI-Device Identifier: 10603295060222
• UDI-Public: 10603295060222
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K013352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2013

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1570-13-090
• Device Catalogue Number: 157013090
• Device Lot Number: EW9NH1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 07/28/2020
• 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: 50 YR