MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ5 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-11-110

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Nausea (1970); Nerve Damage (1979); Loss of Range of Motion (2032); Tissue Damage (2104); Weakness (2145); Dizziness (2194); Test Result (2695); Not Applicable (3189)

Event Date 04/25/2011

Event Type  Injury  

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.

Event Description

Complaint description: pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported patient with nausea, dizziness, trouble standing, squeaking and nerve damage with left foot drop.Medical records reported left hip clicking after mva, weakness in left foot, toes, ankle and left foot drop related to sciatic and peroneal nerve injury.Revision surgical report noted patient revised for metallic synovitis and found metallic staining of tissues, significant amount of black debris, significant cyst formation behind cup and sciatic stretch injury causing foot drop.The complaint was updated on: (b)(6) 2016.Update ad 24 apr 2018: in addition in what was previously alleged, ppf alleges elevated metal ions.Doi: (b)(6) 2006 - dor: (b)(6) 2011; (left hip).

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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SUMMIT POR TAPER SZ5 HI OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7818510
• MDR Text Key: 118292836
• Report Number: 1818910-2018-67733
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060062
• UDI-Public: 10603295060062
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

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
• Device Operator: Health Professional
• Device Model Number: 1570-11-110
• Device Catalogue Number: 157011110
• Device Lot Number: A28AX1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 82