MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ8 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157011150

Device Problems Material Disintegration (1177); Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Inadequate Osseointegration (2646); No Information (3190)

Event Date 05/14/2013

Event Type  Injury  

Manufacturer Narrative

No device associated with this report was received for examination.A complaint database search did find additional related reports against the metal liner and/or femoral head product code and lot number combination(s).However; a review of the device history record(s) associated with this complaint was not required per (b)(4).A worldwide complaint database search found no additional related reports against the remaining product code/lot code combination(s).A corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Litigation alleges that the patient suffers from pain, discomfort, soreness, difficulty with daily living activities, and toxic cobalt chromium metal ions and particles to be released into the patient's blood, tissue, and bone.Update (b)(4) 2013 - the complaint has been updated because it was reported that the patient's liner and head were revised on (b)(6) 2013 to address pain, bad tissue, and lots of fluid.The cup was also removed; however, due to the metal-on-metal-related issues reported, it is reasonable to conclude that the cup was not likely to have contributed there is no new information that would affect the mdr decision.Update (b)(4) 2015 - pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated local tissue reaction and osteolysis.The cup was thought to be loose, but was noted to be stable.The stem is being added for the alleged high metal ions-no labs provided.Part/lot is being updated.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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. udi: (b)(4).

Event Description

Ppf alleges loosening of cup, metallosis and elevated metal ions.Added updated patient harm, law firm, updated date of implant, revision surgeon and hospital.Added cup and screw due to alleged loosening.Doi: (b)(6) 2004 - dor: (b)(6) 2013 (left hip).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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 : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ8 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: 4863201
• MDR Text Key: 14248915
• Report Number: 1818910-2015-24124
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/29/2015

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 Expiration Date: 07/31/2009
• Device Catalogue Number: 157011150
• Device Lot Number: Y14FE1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2015
• Initial Date FDA Received: 06/23/2015
• Supplement Dates Manufacturer Received: Not provided; 01/15/2019; 11/17/2019
• Supplement Dates FDA Received: 07/02/2015; 01/18/2019; 12/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 107