MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121722050

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

Patient Problems Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)

Event Date 09/17/2020

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

Patient received primary hip replacement due to osteoarthritis in 2015 (exact date unknown).Revision surgery required as patient presented with pain (~12 months ago).X-ray showed that head/stem had migrated superiorly in related to expected cor in cup.During revision procedure surgeon performed debridement of tissue affected by metallosis.Once within joint space the liner was found to have disassociated from it's designed position and the ceramic head had worn away a portion of the pinnacle shell and caused damage to the hex insert of the single screw.The head, screw and cup were explanted, the surgeon deemed the stem (corail size 10/135deg std offset w collar) as stable and opted to leave it in-situ.Further debridement of tissue was performed along with a wash-out of the joint space.A 52mm gription multihole pinnacle pinnacle shell (x4, 6.5mm screws & hole eliminator), 20mm 50/52 gription tf augment (x4, 5.5mm locking screws) and 5cc of dbx putty was used to treat the acetabular defect and a 32/52mm lipped liner with 32mm +5 articuleze head was used to complete the procedure.Female patient id (b)(6).

Manufacturer Narrative

Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Udi : (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Examination of the provided photograph images finds sufficient evidence to confirm the reported disassociation event and subsequent post disassociation material wear.It was not possible to determine a root cause using only photographic 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.

• Brand Name: PINNACLE SECTOR II CUP 50MM
• 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: 10612895
• MDR Text Key: 209389353
• Report Number: 1818910-2020-21301
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121722050
• Device Lot Number: 7780432
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6.5MM PINNACLE SCREW (LENGTH UNKNOWN); CORAIL AMT COLLAR SIZE 10; CORAIL SIZE 10/135DEG STD OFFSET W COLLAR; DELTA CER HEAD 12/14 32MM +1; DELTA CER HEAD 12/14 32MM +1; PINN CAN BONE SCREW 6.5MMX20MM; PINN MAR +4 10D 32IDX50OD; PINN MAR +4 10D 32IDX50OD; 6.5MM PINNACLE SCREW (LENGTH UNKNOWN); CORAIL SIZE 10/135DEG STD OFFSET W COLLAR; DELTA CER HEAD 12/14 32MM +1; PINN MAR +4 10D 32IDX50OD
• Patient Outcome(s): Required Intervention
• Patient Weight: 160