MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL PINNACLE; METAL ACETABULAR LINER

Catalog Number UNK HIP ACETABULAR LINER METAL

Device Problem Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Joint Laxity (4526)

Event Date 04/26/2022

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

"article entitled "adverse local tissue reaction associated with ceramic-on-metal bearing surface in primary total hip arthroplasty: report of two cases" written by fernando diaz dilernia, md, marcos r.Latorre, md, fernando m.Comba, gerardo zanotti, pablo a.I.Slullitel, and martín a.Buttaro, md published in arthroplasty today on april 26, 2022 was reviewed.The purpose of the study was to present 2 patients who developed an altr complication associated with the metallic component of the com couple in primary tha.Case #1 - 44-year-old woman with bilateral hip osteoarthritis underwent cementless right tha through a posterolateral approach.6 months later, the left tha was performed using the same fixation method using the same approach.The components that were implanted included a 54 mm acetabular cup (pinnacle cup, depuy synthes, (b)(4)), a 36-mm cobalt-chrome insert (pinnacle insert, depuy synthes, (b)(4)), a 36 þ 5-mm ceramic head (biolox delta, ceramtec ag, (b)(4)), and a fully hydroxyapatite porous-coated cementless stem (corail stem, depuy synthes, (b)(4)).There were no intraoperative complications, and the patient had an uneventful recovery adverse events: 3 years post op - the patient presented with groin pain in her right side, squeaking, and a sensation of instability when sitting.Radiographs showed well-aligned and well-fixed implants.Patient underwent a revision and extensive synovitis, signs of metallosis, and abundant synovial fluid were found.After confirming the stability and good position of the acetabular cup and the femoral stem, the metal insert and the ceramic femoral head were removed.Case #2 - 59-year-old man with bilateral hip osteoarthritis underwent simultaneous bilateral thas through a posterolateral approach.A 56-mm acetabular cup (pinnacle cup, depuy synthes, (b)(4)), a 36-mm cobalt-chrome insert (pinnacle insert, depuy synthes, (b)(4)), a 36 þ 1.5-mm ceramic head (biolox delta, ceramtec ag, (b)(4)), and a fully hydroxyapatite porous-coated cementless stem (corail stem, depuy synthes, (b)(4)) were used in both hips.There were no intraoperative complications, and the patient had an uneventful recovery.Adverse events: 10 years post op -the patient presented with progressive left groin pain.Revision surgery was performed through the same posterolateral approach.Extensive synovitis, signs of metallosis, and an altr were evidenced.Given that the cup and the stem were well fixed and well aligned, only the metal liner and the ceramic femoral head were removed.".

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.

• Brand Name: UNK HIP ACETABULAR LINER METAL PINNACLE
• Type of Device: METAL ACETABULAR LINER
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14955535
• MDR Text Key: 295478754
• Report Number: 1818910-2022-12581
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

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 Catalogue Number: UNK HIP ACETABULAR LINER METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 08/24/2022
• 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
• Patient Outcome(s): Required Intervention