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 Bone Fracture(s) (1870); Hypersensitivity/Allergic reaction (1907); Pain (1994); Joint Dislocation (2374); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(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

"literature article abstract entitled, ¿complications after hip resurfacing using the asr prosthesis in patients with osteoarthritis¿ by m.Klein, et al, published by z orthop unfall (2008), pp.179-84, doi: 10.1055/s-2008-1038397, was reviewed for mdr reportability.The purpose of this study was to evaluate peri- and postoperative complications and the clinical/radiological results after hip resurfacing with the asr prosthesis in patients with osteoarthritis.Materials: 115 asr cups and heads implanted between 1/2005 and 7/2006.At the time of follow-up an x-ray (a.P.And axial) of the operated hip was performed in addition to the to standard clinical examination.To measure the functional outcome the harris hip score was used.Results: there were 18 total complications.Three non-trauma-related femoral neck fractures were seen after a mean of 58 days (range: 41 to 70 days).One trauma-related femoral neck fracture was found after 7 months.Neural complications were found in two patients.In 8 patients a revision of the acetabular component was necessary, the reasons for revision surgery were unspecified.3 dislocations were treated without further revision.One revision was necessary because of a persisting pseudotumor without infection.No infections or thromboembolic complications were seen.The mean harris hip score developed from preoperative 59 points (range: 50 to 65 points) to postoperative 96 points (range: 85 to 100 points).Conclusions: excellent early postoperative results can be reached by hip resurfacing.This article is an abstract.No further information regarding patients or implanted products was available for review.This is for an asr cup and head.".

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 ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9189227
• MDR Text Key: 173025499
• Report Number: 1818910-2019-109056
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• 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: 12/18/2019
• 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
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention