MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-36-310

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544); Joint Laxity (4526); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Date 02/15/2021

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

Revision pinnacle metal liner because of metalosis.The head has been revised as well.

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.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: examination of the returned device and x-ray images did not identify any product defects or anomalies.Depuy considers the investigation closed.Should additional info be received, 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint # : pc-(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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

The revision surgery occurred on (b)(6) 2021 on the left hip.Prior to revision, patient was having pain and instability in the left hip.Primary implantation was in 2010 and since then had occasional feelings of "skipping" in the hip.Patient was dislocated in 2017 and 2020 requiring a "readjustment" in the hospital both times.The patient has had limping, walking difficulty and fear of falling.The patient's left leg was 5mm longer than the right.Surgeon also stated that the patient had a r tha in 2009 requiring revision in 2015 due to metallosis, though no indication of manufacturer.The revision surgery was performed where heavy, dark effusion and a large mass of brittle granulation tissue was found.Osteolysis was noted around the proximal part of the stem and around the cup.The cup and stem were left in situ.

• Brand Name: DELTA CER HEAD 12/14 36MM +1.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11527662
• MDR Text Key: 241394495
• Report Number: 1818910-2021-05551
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033615
• UDI-Public: 10603295033615
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-36-310
• Device Catalogue Number: 136536310
• Device Lot Number: 3190861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 03/12/2021; 04/07/2021; 05/12/2021
• Supplement Dates FDA Received: 03/23/2021; 04/20/2021; 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CANCELLOUS BONE SCREW 6.5X25MM; CORAIL2 NON COL HO SIZE 12; DELTA CER HEAD 12/14 36MM +1.5; PINNACLE MTL INS NEUT36IDX50OD; PINNACLE SECTOR II CUP 50MM
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR