MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +5; HIP CERAMIC FEMORAL HEADS

Model Number 1365-36-320

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Injury (2348); Test Result (2695)

Event Date 03/09/2017

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

Left hip arthroplasty on (b)(6) 2011.In (b)(6) 2017, the patient was subjected to a revision surgery due difficulty in walking, feeling of instability.In addition high ions levels of cr and co were detected.Update (b)(6) 2017: claim notification, litigation and medical records of pinnacle received.In addition to what was previously alleged,claim letter alleges pain, noise(scratching and tearing) and bone erosion.(b)(6) 2011; (b)(6) 2017 (left hip) pinnacle.

Manufacturer Narrative

Pc(b)(4).No device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Manufacturer Narrative

Product complaint # (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.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.A complaint was received regarding the revision of a pinnacle corail hip stating: "(b)(6) was subjected to a left hip arthroplasty at (b)(6) on (b)(6) 2011.In (b)(6) 2017 the patient was subjected to a revision surgery due difficulty in walking, feeling of instability.In addition high ions levels of cr and co were detected." claim notification, litigation and medical records of pinnacle were received.In addition to what was previously alleged, the claim letter alleges pain, noise (scratching and tearing) and bone erosion.Further, the translated medical records specify that the acetabular cup, insert and head were revised.It also indicates that the revision was performed due to loosening of the acetabular component.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination (136536320/3221375).Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint samples associated with this report, it was not possible to determine if the devices failed to meet specifications at the time they were released for distribution.The devices associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.Overall, from the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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: DELTA CER HEAD 12/14 36MM +5
• Type of Device: HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7154007
• MDR Text Key: 96022138
• Report Number: 1818910-2017-52704
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033622
• UDI-Public: 10603295033622
• Combination Product (y/n): N
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/05/2017

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 Expiration Date: 10/27/2015
• Device Model Number: 1365-36-320
• Device Catalogue Number: 136536320
• Device Lot Number: 3221375
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 08/07/2018; 03/11/2021; 09/14/2021
• Supplement Dates FDA Received: 08/29/2018; 03/23/2021; 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: CORAIL2 STD SIZE 13; DELTA CER HEAD 12/14 36MM +5; PINNACLE MTL INS NEUT36IDX52OD; PINNACLE SECTOR II CUP 52MM
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR