MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ7 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157011135

Device Problem Loss of Osseointegration (2408)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Swelling (2091); Discomfort (2330); Hypoesthesia (2352); Inadequate Osseointegration (2646)

Event Type  Injury  

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.Initial reporter occupation: lawyer.

Event Description

Litigation papers allege that patient experienced severe pain and discomfort, swelling, numbness, and difficulty walking.Doi: (b)(6) 2005.Dor none reported, (right hip).Doi: (b)(6) 2006.Dor none reported, (left hip).Left hip doi: (b)(6) 2006.Dor: (b)(6) 2012, right hip (b)(6) 2005, no revision.In addition to what were previously alleged, ppf alleges fracture (bone), loosening of stem, metal wear and metallosis.Added lawyer and patient harms.Updated the product details of head and liner.Added stem due to the alleged loosening.An unknown hip implant has been added to capture the allegation of fracture as it's unknown where the fracture was.Doi: (b)(6) 2005.Dor: none reported, (right 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.

• Brand Name: SUMMIT POR TAPER SZ7 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: 8855557
• MDR Text Key: 153108159
• Report Number: 1818910-2019-99889
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060086
• UDI-Public: 10603295060086
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/31/2012

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 157011135
• Device Lot Number: Z2JJE1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 118