MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 54MM; HIP ACETABULAR CUP

Catalog Number 121722054

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

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Pain (1994); Joint Swelling (2356); Osteolysis (2377); No Code Available (3191)

Event Date 01/27/2015

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

Pfs and medical records received.Pfs reported second revision dated (b)(6)15, pain, clicking after first revision, swelling, and could not go from sitting position on floor to standing.Pfs also reported patient had a painful pinnacle total left hip (b)(4).Revisions surgical note reported 1500ml estimated blood loss, necrotic tissue and metallosis found between the liner and cup and osteolysis over the anterior proximal femur.Liner was reported previously on (b)(4).

Manufacturer Narrative

Update(b)(6) 2016 - pfs and medical records received.Pfs reported second revision dated (b)(6) 2015, pain, clicking after first revision, swelling, and could not go from sitting position on floor to standing.Pfs also reported patient had a painful pinnacle total left hip ((b)(4)).Revisions surgical note reported 1500ml estimated blood loss, necrotic tissue and metallosis found between the liner and cup and osteolysis over the anterior proximal femur.Liner was reported previously on (b)(4).Examination of the reported devices were not possible as they were not returned.A search of the complaints databases identified other reports against the femoral stem.Review of device history records finds no related manufacturing deviations or anomalies that would have contributed to the reported event.No other similar or related complaints found against the remaining product/lot code combinations since their release to distribution.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 still 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

Ppf alleges loosening of stem 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).

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.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: PINNACLE SECTOR II CUP 54MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5647113
• MDR Text Key: 44986171
• Report Number: 1818910-2016-19137
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/19/2016

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: 08/11/2010
• Device Catalogue Number: 121722054
• Device Lot Number: Z2SDP1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/11/2016
• Supplement Dates Manufacturer Received: Not provided; 03/04/2019; 02/25/2020
• Supplement Dates FDA Received: 06/30/2016; 03/12/2019; 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 68