MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. S-ROM*SLEEVE PRX ZTT, 18B-LRG; HIP FEMORAL STEM/SLEEVE

Catalog Number 521485

Device Problem Connection Problem (2900)

Patient Problem Osteolysis (2377)

Event Date 12/07/2016

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

Due to the osteolysis caused by abrasion powder from poly-dial insert and the loosening of ztt-cup.The surgeon tried to separate the s-rom stem and s-rom sleeve by using separator about 1 hour, but the stem and sleeve could not be separated because they were firmly fixed.The stem and sleeve was removed by using chisel.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

The complaint states primary tha for oa had taken place on (b)(6) 1998.Due to the osteolysis caused by abrasion powder from polydial insert and the loosening of ztt¿cup, revision surgery took place on (b)(6) 2016.The surgeon tried to separate the s-rom stem and s-rom sleeve by using separator about 1 hour, but the stem and sleeve could not be separated because they were firmly fixed.The stem and sleeve was removed by using chisel.A complaint database search did not identify any anomalies.The devices were reviewed by bioengineering; sleeve component is locked to the stem as described in the complaint.Some corrosion is observed between the two components, however this cannot be further investigated (detachment of sleeve from stem) without destructive testing authorization.Stem/sleeve taper cannot be scored as they are locked together.Circular marks were noted on the underside of the stem neck, below the taper.It is not possible to identify if it is due to impingement or removal damage.A deformed area was found around the lipped region on the poly insert.It is not possible to determine the cause but could be more likely due to dislocation than impingement.Information received does not indicate patient experienced any dislocations.Wear is obvious on the poly insert bearing surface with a notable change in bearing surface gradient as well as obvious 3rd body wear.Retrieval damage is observed around the edge of the poly insert.Information suggests the liner was in vivo for around 18 years.Some bone ingrowth was noted is portions of the cup, and not on the entire implant.Neither loosening or osteolysis could be confirmed with the information provided at this stage.Stem-sleeve taper could not be further analyzed, neither were the instruments returned (under (b)(4)) for investigation, therefore root-cause for the surgical delay could not be determined.Without further information, the root cause of the complaint cannot be determined.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received, the complaint shall be reopened and investigated further.Post market surveillance is per sep 419.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.

• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6221034
• MDR Text Key: 63797021
• Report Number: 1818910-2017-10100
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2016

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 Catalogue Number: 521485
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 01/04/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/24/2017; 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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