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

Catalog Number 157011110

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Joint Swelling (2356); Osteolysis (2377); No Code Available (3191)

Event Date 05/07/2012

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was revised to address mal-positioning of the cup, increased metal ion levels, metallosis, and osteolysis.Update 1/19/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported pain, swelling, grinding, movement of hip joint, metallosis and increased metal ion levels.Medical records reported the right hip made some "funny noises" creaking and squeaking, discomfort, felt symptoms of instability like hip "realigning itself", serum ion levels were obtained and elevated, right leg longer than left leg, acetabular component malpositioned and fluid around the hip.The revision surgical report noted metallosis, metal stained synovium and tissues, periarticular disease, acetabular component malpositioned in abduction and excessive anteversion, copious amount of dark stained fluid, cavitary defect anterior column of acetabulum extending into the pubic root, small defect in medial wall and quite a bit of bone loss in the pubic root.There was no report of osteolysis in the revision surgical report.Reported lab results were greater than 7 parts per billion.Stem is being added to the complaint.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution.X-ray review confirms implant malpositioning.Medical records were reviewed.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been 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.

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 metal wear.

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 #
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> (b)(4).Investigation summary
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> 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 POR TAPER SZ5 HI OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5406541
• MDR Text Key: 37354208
• Report Number: 1818910-2016-12526
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK003523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/11/2016

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: 11/11/2016
• Device Catalogue Number: 157011110
• Device Lot Number: A5LBVA000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 02/03/2016
• Supplement Dates Manufacturer Received: Not provided; 02/11/2019; 12/02/2019
• Supplement Dates FDA Received: 03/17/2016; 02/14/2019; 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 78