MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ7 STD OFF; HIP FEMORAL STEM

Catalog Number	157002135
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/10/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Der states that the patient has been having pain.Surgeon ordered an ion level test suspecting trunionosis.The cobalt serum level was 8.8 ug/l when tested on (b)(6) 2017.There was noted darkening of the synovial tissue.There was also some noted black substance inside the head.The head was not in the possession, but hospital policy is that the implant had to be cleaned and sterilized.It was not loose on the taper.Surgeon elected to keep the stem in place and utilized a ceramic head.He examined it close and felt like there was little to no wear.Doi: (b)(6) 2011; dor: (b)(6) 2018 right hip.
Additional Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT DUOFIX TAP SZ7 STD OFF
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7224180
• Report Number: 1818910-2018-52203
• Device Sequence Number: 16397933
• Product Code: LPH
• UDI-Device Identifier: 10603295059486
• UDI-Public: 10603295059486
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 157002135
• Device Lot Number: ED2E21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 83