MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-352

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

Patient Problems Ossification (1428); Fatigue (1849); Foreign Body Reaction (1868); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Discomfort (2330); Ambulation Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 01/28/2019

Event Type  Injury  

Event Description

The patient was revised for unknown reason.Doi: unknown, dor: (b)(6) 2019, unk hip.

Manufacturer Narrative

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

Event Description

After review of medical records the patient was revised due to metallosis.Patient experienced pain, instability,discomfort, difficulty sleeping, walking difficulty, impaired mobility, patient unable to tolerate normal daily activities due to pain and decreasing endurance, decreased mobility, and increase pain due to lower quadrant dysfunction with right hip muscle strain.Patient alleges elevated metal ion but laboratory data showed below 7ppb.Laboratory findings stated that punctuate mineralization is noted approximately 1.8cm superior to the expected attachment to the gluteus medius and may represent heterotopic ossification or sequela of partial tear/retraction, and edema, and there is small joint effusion, inflammation, and there is alarge amount fluid around the right hip.There is synovial thickening and/or nodularity around the fluid inferiorly.Patient has iliopsoas bursitis, stiffness, weakness, subluxation.Revision notes stated that metal head and liner were removed during revision of the right hip.Medical records that involved non mom implants.On (b)(6) 2019 the patient had a revision right hip with head/liner exchange to address metallosis.Implants removed were metal on metal and the implants were implanted were depuy poly liner, depuy ceramic femoral head.Medical records (b)(6) 2019 -patient is 2 weeks out from revision of metal on metal.The patient is doing very well at this time, with minimal pain.Patient medical history includes: degenerative disc disease, lumbosacral, hypertension, pain, rheumatoid arthritis.There are no noted harms/allegations against the depuy poly liner and depuy ceramic head placed on (b)(6) 2019.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: update 14-oct-2022.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: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

• Brand Name: PINNACLE MTL INS NEUT36IDX52OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15589331
• MDR Text Key: 301593121
• Report Number: 1818910-2022-20270
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

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 Model Number: 1218-87-352
• Device Catalogue Number: 121887352
• Device Lot Number: A1PE11000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AML SM STATURE 12.0MM; ARTICULEZE M HEAD 36MM +5; PINNACLE SECTOR II CUP 52MM
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 79 KG