MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX54OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887354

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Injury (2348); Depression (2361); Joint Dislocation (2374); Osteolysis (2377); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

(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

Jan 24 2018: pinnacle litigation received.Litigation alleges defective and has caused damage to hip joint.Doi: (b)(6) 2008: dor: not reported (unknown hip).

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.If information is obtained that was not available for the initial 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 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.   no code available ((b)(4)) is used to capture (device revision or replacement).

Event Description

Pfs alleges pain, limitation, walking difficulty, bout of inflammation, metallosis reaction, psuedotumor, dislocation, weight gain, depression and clunk.After review of medical records the patient was revised for failed left tha with presumed adverse reaction to metal debris.Operative notes reported that there was egress of greening-yellowish thin fluid.There was abundant rind-like material around the hip, consistent with an adverse reaction to metal debris.Some capsule tissues were necrotic and there was a pasty tissue associated with lysis around the joint itself.The trunnion has one small spot of corrosion and some small amount on the femoral head.It was also reported that there was greater trochanteric bursitis.There were two screws that appear to sit a bit proud.

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 MTL INS NEUT36IDX54OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7276859
• MDR Text Key: 100278164
• Report Number: 1818910-2018-53543
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K003523
• 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: 01/24/2018

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: 06/30/2013
• Device Catalogue Number: 121887354
• Device Lot Number: 2653731
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 03/09/2018; 03/10/2020; 03/30/2020
• Supplement Dates FDA Received: 03/13/2018; 03/27/2020; 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 70