MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4) surgical intervention.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The literature article entitled, "spontaneous dissociation of anatomic medullary locking a plus (aml a plus) femoral component at the head-neck interface" written by ketan pande, juzaily fekry leong, and ngai nung lo published by journal of orthopaedic case reports july - sep: 5(3):page 48-50 doi:10.13107/jocr.2250-0685.306 was reviewed for mdr reportability.The article discusses a case of a 21 year old male who received a depuy aml a plus femoral stem, cocr head and duraloc acetabular liner with shell in 2002.Twelve years later he presented with sudden onset of pain along with inability to move left hip while turning in bed.Radiographic images reveal implant fracture on the stem trunnion as the article refers to it as "dissociation" of the components and notes "failure of taper" with noted wear at of the trunnion and noted wear of the poly liner.Additionally, wear was noted on the femoral head component.Revision surgery included removal of the stem, head and liner.The cup was left intact as it was well fixed.The article reports: "two years after revision surgery, patient reported no pain and was ambulating without support.The extended femoral osteotomy had healed well.There was evidence of heterotopic ossification resulting in some restriction of movements." however, no further details were given in regards to any interventions provided post revision surgery nor the details of utilized products.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device was received.Root cause undetermined.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9129449
• MDR Text Key: 166042422
• Report Number: 1818910-2019-106537
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: BX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2019
• 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