MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT40IDX56OD; HIP ACETABULAR LINERS

Catalog Number 121887456

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Adhesion(s) (1695); Erosion (1750); Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Joint Dislocation (2374); No Code Available (3191)

Event Date 09/14/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.This report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).

Event Description

Plaintiff's preliminary disclosure received.Ppd reported 2nd revision of the right hip.Reason for revision is unknown.Doi: (b)(6) 2009 - dor: (b)(6) 2017 (right hip).

Manufacturer Narrative

Product complaint # (b)(4).

Event Description

After review of medical record, patient was revised to address metal on metal bearing hip prosthesis, metallosis, cyst formation, and recurrent dislocation.Revision notes reported that the fluid also looked consistent with metalosis with a light tan, gritty consistency.Therefore, the synovectomy was removed along with periarticular cyst which was moderate sized and wrapping around the greater trochanter.Xray reveal that femoral stem is beginning to migrate causing endosteal erosion.Doi: (b)(6) 2009 - dor: (b)(6) 2017 (right hip).

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

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.H10 additional narrative: added: a2, b5, b6, h6(patient).No code available use for medical device removal.

Event Description

After review of medical records patient was revised to addressed metallosis with adverse local tissue reaction, chronic synovitis with periarticular cyst formation and recurrent dislocation.Operative notes indicated increasing pain.Scar tissue was dissected and found significant synovitis due to metallosis.Fluid also looked consistent with light tan, gritty consistency.Added age and laboratory result.Updated patient harm.Doi: (b)(6) 2009 dor: (b)(6) 2017 right hip 2nd revision.

• Brand Name: PINNACLE MTL INS NEUT40IDX56OD
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8491246
• MDR Text Key: 141187123
• Report Number: 1818910-2019-90063
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2019

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: 07/31/2014
• Device Catalogue Number: 121887456
• Device Lot Number: 2956562
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 04/17/2019; 05/02/2019; 01/23/2020
• Supplement Dates FDA Received: 04/25/2019; 05/16/2019; 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 72