MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ4 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157012100
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Weakness (2145); Depression (2361); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Date of Event	04/20/2011
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.Occupation: attorney.(b)(4).
Event or Problem Description
Complaint description: litigation alleges the patient suffers from pain and weakness.Update 01/12/17 ¿ pfs and medical records received.After review of the pfs and medical records for mdr reportability, alleges pain, difficulty walking, getting in and out of car, inability to do liquid housekeeping chores, depression, limited range of motion and weakness in hip and leg, and trouble sleeping.Revising surgeon noted in description that "anterior half of abductors were avulsed, and there was approximately 100 ml of yellow-tinged fluid in the hip".Also, "some metal staining around the periphery of the acetabulum".The "metal stained lining" was sent for pathology, "which was negative for acute inflammation, but positive for perivascular lymphocytic infiltration consistent with an adverse reaction to the metal-on-metal bearing".Altr and poor joint mechanics: rom harms added to complaint, and fda codes for altr, loss of rom, depression, and weakness submitted.Update ad 30 aug 2018: receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges metal wear, metallosis, and elevated metal ions.Added stem due to elevated metal ions.
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.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 SZ4 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: 8528078
• Report Number: 1818910-2019-91039
• Device Sequence Number: 11391977
• Product Code: LPH
• UDI-Device Identifier: 10603295060154
• UDI-Public: 10603295060154
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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 Catalogue Number: 157012100
• Device Lot Number: B4VF81000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 12/09/2019
• 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: 53 YR
• Patient Weight: 2