MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 SUMMIT DUOFIX TAP SZ3 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157002090
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Tissue Damage (2104); Discomfort (2330); Test Result (2695)
Date of Event	06/22/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 36 mm +1.5; pinnacle mtl ins neut36idx58od; unknown hip acetabular cup; summit duofix tap sz3 std off.Initial reporter occupation: non-healthcare professional.
Event or Problem Description
Litigation papers allege: friction and wear between the cobalt-chromium metal head and cobalt chromium metal liner has caused large amounts of toxic cobalt chomrium metal ions and particles to be released into patient's blood and tissue and bone surrounding the implant.As a result, patient has been experiencing severe pain and discomfort and inflammation in her right leg; popping and clicking sound in her right hip, sensation that the pinnacle device is unstable and will give out on him, inability to walk moderate or long distances, inability to sleep on her right side without severe pain, inability to sit for moderate to long periods of time, metallosis, cobalt chromium metal toxicity and other complications.Doi: (b)(6) 2003 - dor: (b)(6) 2011 (right hip).Update (b)(6) 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.In addition to what was previously alleged, ppf alleges dislocation with closed reduction.Updated patient's initials, and noted the patient's residence.Added patient's date of birth and added the firm name.Added account name/revision hospital.Added stem 157002090 lot # w4sfn1001.Doi: (b)(6) 2003 - dor: (b)(6) 2011 (right hip).
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(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 SZ3 STD OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7784482
• Report Number: 1818910-2018-66707
• Device Sequence Number: 173777
• Product Code: LPH
• UDI-Device Identifier: 10603295059448
• UDI-Public: 10603295059448
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2018

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 Catalogue Number: 157002090
• Device Lot Number: W4SFN1001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 07/23/2018; 08/27/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 08/15/2018; 09/14/2018
• 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: 50 YR