MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121722056

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Unspecified Infection (1930); Nausea (1970); Pain (1994); Anxiety (2328); Depression (2361); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 10/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation alleges patient suffers from pain.Update ad 30 aug 2018: (b)(4) has been re-opened under (b)(4) due to receipt of ppf, sticker sheets and implant records.In addition to what were previously alleged, ppf alleges metal wear, metallosis, infection and bone fracture.Updated patient initials, implant date and the details of the head and liner product.Added date of revision, account name, surgeon, law firm and an impacted product record for the stem, cup, hole eliminator and three bone screws was added due to alleged infection.At this time it¿s unknown where the fracture occurred.If/when more information is received, the pc will be updated as needed.Doi: (b)(6) 2010; dor: (b)(6) 2014 (left hip).Please see (b)(4) for the right hip.

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.

Event Description

Pfs alleges lack of mobility, chronic insomnia, mental and emotional strain, felt ill(anxiety, depressed, nausea, tired).After review of medical records, patient was revised to addressed septic left hip arthroplasty.Operative notes indicated upon debridement inferior fascial repair was failed and there was gross pus present.Acetabular component which did free from bony ingrowth but able to remove it with very little or no bone loss.Confirmed in medical records that fracture was intended for the right femur.Added age, height and weight of patient.Doi: (b)(6) 2010, dor: (b)(6) 2014, left hip.Cn(wipro).

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 # (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 SECTOR II CUP 56MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9273719
• MDR Text Key: 178064859
• Report Number: 1818910-2019-113889
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009849
• UDI-Public: 10603295009849
• Combination Product (y/n): N
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121722056
• Device Lot Number: E33C81000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 12/03/2019; 12/23/2019
• Supplement Dates FDA Received: 12/18/2019; 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 118