MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX56OD; HIP ACETABULAR INSERT/LINER

Catalog Number 121887456

Device Problems Naturally Worn (2988); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Tissue Damage (2104); Muscular Tics (2161); Joint Swelling (2356); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

Additional narrative: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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

Patient was revised for osteolysis.

Manufacturer Narrative

Depuy still considers this investigation closed at this time.

Event Description

Update rec'd 2/5/2016: litigation received.Litigation also alleges elevated metal ions.The stem is being added to the complaint.A doi was provided.This complaint was updated on: 2/15/2016.

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 provided product and lot code combinations since their release to distribution.A search of the complaints databases and/or a review of stem device history records were not possible as the required product/lot code combination was not provided.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 this investigation closed at this time.

Event Description

Update 6/6/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported pain that limited mobility and continues to happen when walking long distances.Mri reportedly showed osteolysis, small joint effusion and metallosis.Lab results for metal ions were less than 7 parts per billion.Revision surgical report noted groin and lateral pain, significant osteolysis with bone graft at the anterior aspect of femur and necrotic tissue debrided.

Manufacturer Narrative

Udi: (b)(4).Examination of the reported devices was not possible as they were not returned.A review of stem device history records identified no related manufacturing deviations or anomalies that would have contributed to the reported event.A search of the complaints databases finds no other reports against the remaining provided product and 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 alleged metal wear.

Manufacturer Narrative

Product complaint #: (b)(4).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 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.H6 patient code: no code available (3191) was used to capture surgical intervention.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE MTL INS NEUT40IDX56OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5047782
• MDR Text Key: 24755984
• Report Number: 1818910-2015-29550
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PK062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Remedial Action: Other
• Type of Report: Followup,Followup,Followup,Followup,Followup
• Report Date: 09/01/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2013
• Device Catalogue Number: 121887456
• Device Lot Number: 2516812
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 04/04/2019; 05/27/2020
• Supplement Dates FDA Received: 03/04/2016; 03/31/2016; 07/05/2016; 08/27/2016; 05/02/2019; 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 98