MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX56OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887356

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Dyspnea (1816); Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Heart Failure (2206); Injury (2348); Joint Dislocation (2374); Test Result (2695); No Code Available (3191)

Event Date 08/15/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(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

Pfs and medical records received.Pfs alleges psuedotumor, dislocation, metal wear, metallosis, pain and elevated metal ions.After review of medical records, the patient was revised due to dislocation and failed right total hip arthroplasty secondary to metal-on-metal wear debris and pseudotumor formation.Operative notes reported heterotropic ossification, a large pseudotumor and a erosive damage proximally was noted on the calcar.Medical records also indicated that patient was admitted on (b)(6) 2012 due to acute right hip pain and instability, with recurrent chest pain and congested heart failure, on (b)(6) 2011 for leg swelling, shortness of breath and infection of the right thigh and on (b)(6) 2011, patient undergone debridement to fascia of chronic wounds of the right thigh, 9 cm x 8 cm and 7 cm x 8 cm.And split-thickness skin graft to right thigh wounds, right thigh donor site.Doi: (b)(6) 2004; dor: (b)(6) 2012; right.The patient has bilateral hip implants, please see (b)(4) for the left hip.

Manufacturer Narrative

Udi: (b)(4).(b)(4) used to capture medical device removal and blood heavy metal increased.

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.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 NEUT36IDX56OD
• 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: 9396622
• MDR Text Key: 168683052
• Report Number: 1818910-2019-119035
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121887356
• Device Lot Number: 1133961
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 11/05/2019; 12/13/2019
• Supplement Dates FDA Received: 12/04/2019; 12/23/2019
• 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: 120