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

Catalog Number	157002090
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Tissue Damage (2104); Hypoesthesia (2352); Test Result (2695); No Code Available (3191)
Date of Event	10/21/2016
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.
Event or Problem Description
Complaint description: litigation alleges patient was revised to due to pain, audible clicking sounds, metallosis, numbness, locking of the hip, and other complications.Update jun 30, 2017: litigation received.After review of litigation, there is no new information added that changes the mdr reportability.This complaint was updated on: jul 11, 2017.Update jul 05, 2017: legal medical records received.After review of medical records for mdr reportability it was reported that the patient was revised to address pain and soft tissue reaction.On her last visit from (b)(6) 2016, the patient requested for blood work which demonstrated slightly elevated cobalt and chromium levels and an mri which demonstrated an adverse soft tissue reaction with substantial joint effusion.On the revision note it was reported that, when the hip joint was exposed, there was a metallic stained synovial fluid.A mild-to-moderate amount of metallic debris staining and synovial.In addition, the femoral head was removed and retain the stem.Clinical notes state inflammation around hip.There were no laboratory values provided for the cobalt/chromium.This complaint was updated on: jul 13, 2017.Update ad 19 apr 2018: (b)(4) has been reopened under (b)(4) due to receipt of pfs, ppf and sticker sheets.There are no new allegations reported.Added updated impacted products.Added stem for the alleged elevated metal ions.Doi: (b)(6) 2010 - dor: (b)(6) 2016 (left hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.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 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: 7771999
• Report Number: 1818910-2018-66294
• Device Sequence Number: 1392082
• Product Code: LPH
• UDI-Device Identifier: 10603295059448
• UDI-Public: 10603295059448
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018

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 Expiration Date: 08/31/2014
• Device Catalogue Number: 157002090
• Device Lot Number: EC7BH1
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 12/10/2019
• 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: 58 YR
• Patient Weight: 92