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

Model Number	1570-02-090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Hypersensitivity/Allergic reaction (1907); Pain (1994); Weakness (2145); Discomfort (2330); Ambulation or Postural Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Date of Event	12/10/2009
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
Complaint description: new etq record created in order to update etq (legal system) complaint number (b)(4).Reason for original complaint: patient had a reaction to metal.Update rec'd 5/19/2015: litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from pain, discomfort, and difficulty walking.Update 11/20/2015: pfs and medical records received.Pfs and medical records reviewed for reportability.Pfs reported difficulty with activities of daily living, emotional distress, consequences related to metal ion exposure, painful itchy rash, dislocations, hip fracture, confined to wheelchair, loss of independence and homebound.Medical records and revision surgical report noted swelling in left groin, large fluid collection, necrosis of tissue and muscle, metal reaction and weakness.There were no lab tests for metal ions within medical records reviewed.There was no report of dislocation or hip fracture in revision surgical report.Update ad 05 sep 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges elevated metal ions.Doi: (b)(6) 2007 - dor: (b)(6) 2009 (left hip).This pc is for the first revision of the left hip.Please see (b)(4) for the second revision and (b)(4) for the third revision.Patient is bilateral.See (b)(4) for the right hip.
Additional Manufacturer Narrative
Udi: (b)(4).(b)(4) used to capture the surgical intervention.
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.

• Brand Name: SUMMIT DUOFIX TAP SZ3 STD 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: 9273762
• Report Number: 1818910-2019-113896
• Device Sequence Number: 16180778
• Product Code: LPH
• UDI-Device Identifier: 10603295059448
• UDI-Public: 10603295059448
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2015

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: 1570-02-090
• Device Catalogue Number: 157002090
• Device Lot Number: B2CG11000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 12/22/2019; 06/16/2020
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 12/27/2019; 06/17/2020
• 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: 63 YR
• Patient Weight: 104