MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT CEMENTED STEM SZ5 HI; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157013110
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Swelling (2091); Tissue Damage (2104); Discomfort (2330); Test Result (2695); No Code Available (3191)
Date of Event	04/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.Corrective action was not indicated.Initial reporter occupation: non-healthcare professional "attorney".(b)(4).
Event or Problem Description
Litigation alleges patient was revised to address swelling, discomfort, pain, dislocation, loosening and infection.Metallosis was also noted.Update: in addition to what was previously reported the pfs reports swelling, and inability to walk.The medical records from (b)(6) 2013 report bilateral hip fractures.The patient was revised to address infection 8 years after primary surgery.Update ppf alleges metal wear and elevated metal ions.Doi: (b)(6) 2005; dor: (b)(6) 2016, (left hip).

• Brand Name: SUMMIT CEMENTED STEM SZ5 HI
• 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: 8554900
• Report Number: 1818910-2019-91705
• Device Sequence Number: 16724243
• Product Code: JDI
• UDI-Device Identifier: 10603295060246
• UDI-Public: 10603295060246
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K013352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2016

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: 157013110
• Device Lot Number: ZC1B51000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/26/2019
• 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: 84 YR
• Patient Weight: 39