MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX56OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-456

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

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/19/2021

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

Clinical notification received for revision of right total hip arthroplasty to address dislocation and metallosis on (b)(6) 2007, the patient had a right press-fit total hip arthroplasty to address end-stage osteoarthritis.Depuy components were utilized, including s-rom stem.The cup was noted to have been placed in about 40-45 degrees open abduction and about 25 degrees anteversion that matched her version anatomically.There were no complications noted during the surgery.On (b)(6) 2021, the patient had a revision right total hip arthroplasty with acetabular cup/liner and femoral head, to address failed right hip, recurrent instability, metallosis with mild adverse reaction to metal debris.The patient has had multiple dislocation which included pain and swelling prior to surgery.The surgeon included in his findings: mild adverse reaction to metal debris, most likely impingement of the neck on the metal liner, mild trunnionosis ¿little bit of lysis and/or just stress shielding in the bone in the acetabulum, and a pseudotumor.The acetabular cup was noted to be ¿slightly malpositioned, slightly vertical, slightly over-anteverted¿.Depuy components were implanted during this procedure.Date of implantation: (b)(6) 2007, date of revision: (b)(6) 2021, (right hip).Treatment: revision of acetabular cup, acetabular liner, and femoral head.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Provided x-ray images have been reviewed.Nothing indicative of a product problem is identified.There is no dislocation event depicted.A root cause for the reported problems cannot be determined using the provided images.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: h5.

• Brand Name: PINNACLE MTL INS NEUT40IDX56OD
• 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: 11278984
• MDR Text Key: 230458786
• Report Number: 1818910-2021-02404
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1218-87-456
• Device Catalogue Number: 121887456
• Device Lot Number: 2385710
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 11/13 S-ROM 40MM M SPEC+3; APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 56MM; PINNACLE MTL INS NEUT40IDX56OD; S-ROM*SLEEVE PRX ZTT, 16D-LRG; SROM STM ST,36+6L NK,11X16X150
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 50