MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD; HIP ACETABULAR INSERT/LINER

Catalog Number 121887352

Device Problems Naturally Worn (2988); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Depression (2361); Osteolysis (2377); Ambulation Difficulties (2544)

Event Date 08/04/2017

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.

Event Description

Der states that the surgeon performed a head and liner swap on a patient with metal on metal hip.Bearing failure was due to metalosis from the head and liner rubbing the stem trunnion.Stem and sleeve were well fixed and did not need to be taken out.No further patient information is available.

Manufacturer Narrative

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.

Event Description

Claim letter alleges pain, depression, loss of income, antalgic gait, tenderness to palpation, limited range of motion, discomfort, stiffness, elevated metal ions and metallosis.After review of medical records the patient was revised to address failed left tha secondary to adverse reaction to metal debris.Clinical findings of mri reported there were scattered debris within the joint fluid, alval, mild reactive muscle edema and soft tissue edema around the left hip and there is a clicking and popping sounds.It was confirmed in the operative note reported osteolysis of the femur, adverse reaction to metal debris and pseudotumor formation, a brownish fluid like coffee ground appearance, pseudocyst from the capsule, trunnionosis within the head and trunnion.Morse taper had a lot of metallosis, soft tissue necrosis and implant wear.Lab results for crp and sedimentation rate were elevated.While metal ions level was below 7ppb.

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.H10 additional narrative: added: h6 (device).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 NEUT36IDX52OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6838366
• MDR Text Key: 84363411
• Report Number: 1818910-2017-24020
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/04/2017

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: 121887352
• Device Lot Number: 1065510
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 09/01/2017
• Supplement Dates Manufacturer Received: 10/04/2017; 07/24/2019; 12/06/2019
• Supplement Dates FDA Received: 10/04/2017; 07/26/2019; 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 99