MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR CUP PINNACLE

Catalog Number UNK HIP ACETABULAR CUP PINNACL

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

Patient Problems Cyst(s) (1800); Fall (1848); Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Literature article entitled "pseudotumor and repeated dislocation after total hip arthroplasty with ceramic-on-metal bearing: a case report" written by yin-qiao du, tao luo, jing-yang sun, hai-yang ma, ming ni, and yong-gang zhou.Published by annals of palliative medicine published online/accepted by publisher 15 jul 2020 was reviewed.The article's purpose was to follow the case of a (b)(6) year-old female who underwent multiple revisions and manual reductions involving ceramic-on-metal hip products.The original primary operation occurred in december 2009 involving a cementless pinnacle cup and s-rom stem.Radiographic and intra-operative images can be found on pages 3 and 4 of the literature article.Depuy products with known adverse event(s): femoral head x 2.Femoral stem.Femoral cone.Acetabular cup.Acetabular screws x 2.Acetabular liner.Adverse events: first revision with femoral head exchange to address pain, instability, difficulty walking, and noise.Subsequent multiple manual reductions to address dislocations leading to an eventual head, liner, and acetabular screw x 2 revision to address pain, fall, decreased range of motion, pseudotumor, cyst, edema, osteolysis, necrosis, inflammation, bone injury, and liner metal wear as well a placement of a cable system to address a femoral bone fracture.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The x-ray images and device photographs within the journal article have been reviewed.In reviewing the images, what appears to be a pseudotumor and fluid within the joint was identified.It is not possible however to confirm product failure regarding the reported allegations.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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: UNK HIP ACETABULAR CUP PINNACLE
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12674265
• MDR Text Key: 277950915
• Report Number: 1818910-2021-23168
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

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: UNK HIP ACETABULAR CUP PINNACL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 12/19/2021
• 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
• Patient Outcome(s): Required Intervention