MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 60MM; HIP ACETABULAR CUP

Catalog Number 121722060

Device Problems Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377)

Event Date 07/13/2016

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.(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

The patient has been revised to address a painful hip.**update jul 27, 2016** litigation received.The litigation alleges the patient was revised to address pain.The information received does not change the existing mdr decision.Update rec'd 08/19/2016 - the patient's medical records were received.Medical records were reviewed for mdr reportability.There is no new information that would change the existing mdr decision.The complaint was updated on: 09/07/2016 update (12/1/2016) ¿ pfs and medical records received.After review of the medical records for mdr reportability, litigation alleges pain and limited range of motion/mobility.Revising surgeon indicated in the operative note that there was a large, cystic lesion, at the location of the external rotators, with a "significant chocolate-colored fluid material".He also identified extensive osteolysis, affecting both the greater trochanter and the acetabulum.There was also some corrosion noted on the trunnion when the head was removed.Additional corrosion was noted "along the notches of the acetabulum" after liner was removed.Also indicated greater trochanter fracture "secondary to all these osteolytic defects" which was reduced and cabled.Cup added to complaint.Osteolysis, soft-tissue irritation, bone fracture: major, intraop and poor joint mechanics:rom added to patient harms; corrosion: taper and other added to product harms.The complaint was updated on: 12/19/2016.

Manufacturer Narrative

Additional 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-rays and 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 still considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Update 03/10/2017 (b)(4) medical records received.There is no new information that affects the existing mdr decision.

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.

Event Description

Ppf alleges pseudotumor, metal wear, metallosis and elevated metal ions.

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).

• Brand Name: PINNACLE SECTOR II CUP 60MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6186870
• MDR Text Key: 62755611
• Report Number: 1818910-2016-33661
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/10/2017

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 Catalogue Number: 121722060
• Device Lot Number: Z3DHH1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 02/27/2019; 12/11/2019
• Supplement Dates FDA Received: 01/13/2017; 03/30/2017; 03/07/2019; 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 86