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

Catalog Number UNK HIP ACETABULAR LINER CERAM

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Joint Laxity (4526)

Event Date 03/15/2021

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

It was reported that patient has history of rheumatoid arthritis and avascular necrosis.Patient had bilateral hip replacements in 2006 at the mayo clinic.Right hip implants included a summit porous-coated stem, a 52 mm duroloc ceramic option cup with a ceramic liner, and a 32mm +1 mm ceramic hip head.Patient has had ongoing right hip pain, with increased squeaking in the (b)(6) of 2020.She noted a grinding sensation and instability in her right hip, with increased discomfort while leaning forward.The surrounding hip muscles were increasingly sore, with some pain while walking every day.The replacement surgery noted the presence of a black stain on the ceramic head and on the tip of the ceramic liner.The surgeon suggested the staining was caused by the trunion of the stem rubbing on the rim of the liner.The liner was intact until it was fractured during the removal.The stem remained well fixed and was left in place.The cup and liner of a competitive company was implanted, with depuy 36mm, 1.5 mm ceramic ts head used.Doi: 2006 dor: (b)(6) 2021 right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A photograph of the explanted product was provided.There is sufficient evidence one the face of the liner identified indicating probable impingement while implanted.The root cause however cannot be determined using photography.The information received will be retained for potential series investigations if triggered by trend analysis 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 device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: UNK HIP ACETABULAR LINER CERAMIC
• Type of Device: CERAMIC ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11595348
• MDR Text Key: 243334822
• Report Number: 1818910-2021-06630
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER CERAM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 32MM +1MM CERAMIC HEAD; 52MM DURALOC CERAMIC OPTION CUP; SUMMIT POROUS COATED STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 84