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); Noise, Audible (3273)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)

Event Date 05/15/2015

Event Type  Injury  

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.

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.(b)(4).

Event Description

The literature article entitled, "isolated revision of an acetabular component to a ceramic-on-ceramic bearing in patients under 50 years of age" written by yh.Kim, jw.Park, and js.Kim published by the bone and joint journal accepted by publisher 15 may 2015 was reviewed.The article's purpose was to report on results from isolated revision of an acetabular component utilizing ceramic on ceramic bearing.Data was compiled from 166 patients (187 hips) consisting of 78 men and 88 women with age range 28 to 49 years.Follow up duration range 11 to 19 years.All patients received depuy implants at time of revision surgery.Original implants are not identified.The article does not specify which product platforms are associated with the adverse events.Stems were not discussed and it is reasonable to assume original stems were left intact and used in conjunction with depuy acetabular components.Depuy products: pinnacle cup, duraloc cup, ceramic on ceramic bearing.Adverse events: aseptic loosening of cup (treated by revision to non-depuy cup) clicking noise infection (treated by open debridement with liner exchange and iv antibiotics) dislocation (treated by closed reduction and abduction brace).

• 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
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9636348
• MDR Text Key: 185456801
• Report Number: 1818910-2020-03150
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• 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: 02/27/2020
• 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