MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 5.0MM DIA TPRD HD PER SCRW 55; BONE SCREWS AND PINS : SCREWS

Model Number	1257-55-000
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	04/12/2011
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.Concomitant med products: articuleze m head 36mm +12 hip femoral head; pinnacle mtl ins neut36idx52od hip acetabular liner; pinn revision w/gription 58mm hip acetabular cup; sol 10.5 mma 8.0 full pc 12/14 hip femoral stem; 5.0mm dia tprd hd per scrw 25 acetabular cup screw; pinn can bone screw 6.5mmx50mm acetabular cup screw; 5.0mm dia tprd hd per scrw 25 acetabular cup screw; 5.0mm dia tprd hd per scrw 55 acetabular cup screw; 5.0mm dia tprd hd per scrw 30 acetabular cup screw.Initial reporter occupation: non-healthcare professional ¿ attorney.(b)(4).
Event or Problem Description
Etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint.Litigation papers allege that after surgery friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused large amounts of toxic cobalt-chromium metal ions and particles to be released into the patient's blood and tissue and bone surrounding the implant.As a result, the patient has been experiencing severe pain and discomfort and inflammation in her left thigh and groin.She also experiences a popping and snapping sensation in her hip joint when walking or moving to and from a sitting position.Doi: (b)(6) 2008 - dor: (b)(6) 2011 (right hip).Patient is a resident of (b)(6).Update: 10/15/2012 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records indicate that the patient was revised because of a loose cup, a broken screw and metallosis.Records are available for further review.Update 03 may 2018: (b)(4) has been re-opened under (b)(4) due to receipt of ppf and sticker sheets.In addition to what was previously alleged, ppf alleges metal wear.Added stem and screws.Updated dor.Doi: (b)(6) 2008 - dor: (b)(6) 2011 (right hip).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: h6 (device).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: 5.0MM DIA TPRD HD PER SCRW 55
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 8103197
• Report Number: 1818910-2018-76313
• Device Sequence Number: 1598329
• Product Code: JDI
• UDI-Device Identifier: 10603295019923
• UDI-Public: 10603295019923
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K861979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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 Model Number: 1257-55-000
• Device Catalogue Number: 125755000
• Device Lot Number: CC3EL4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 02/13/2020
• 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: 54 YR
• Patient Weight: 95