MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6570-0-136
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Doing a total hip and putting real implants in.Acc 2 stem was implanted and went to put the ceramic v40 head on.The taper wouldn¿t lock onto the stem with the head.Tried to impact the head multiple times but wouldn¿t lock.Had to open a second head and the taper locked on just fine.Update (b)(6) 2020 : as reported in how was issue noticed: "after the head was placed on the stem and impacted the surgeon always checks to make sure it locks on.When he pulled on the head it popped off.The head was new out of the box.".Update 4/20/2020: "it took about 5 seconds to grab another head and open the box.".
Additional Manufacturer Narrative
Reported event: an event regarding assembly issue involving a ceramic head.The event was not confirmed.Method & results: device evaluation and results: visual inspection of attached images was performed and stated that - scratches can be observed on the inner surface of head.Dimensional inspection - as per the attached dimensional report no dimensional discrepancies found.Functional inspection not performed as product was returned in damage condition.Ma - material analysis is not performed as this is not related to material integrity.Damage consistent with attempted implantation performed dimensional inspection and no dimensional discrepancies found.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that acc 2 stem was implanted and went to put the ceramic v40 head on.The taper wouldn¿t lock onto the stem with the head.Tried to impact the head multiple times but wouldn¿t lock.Had to open a second head and the taper locked on just fine.Visual inspection of attached images was performed and stated that - scratches can be observed on the inner surface of head.Dimensional inspection - as per the attached dimensional report no dimensional discrepancies found.Functional inspection not performed as product was returned in damage condition.Damage consistent with attempted implantation performed dimensional inspection and no dimensional discrepancies found.The event is not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports and photographs/video depicting the gap observed are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
Event or Problem Description
Doing a total hip and putting real implants in.Acc 2 stem was implanted and went to put the ceramic v40 head on.The taper would not lock onto the stem with the head.Tried to impact the head multiple times but would not lock.Had to open a second head and the taper locked on just fine.Update 03/april/2020: as reported in how was issue noticed: "after the head was placed on the stem and impacted the surgeon always checks to make sure it locks on.When he pulled on the head it popped off.The head was new out of the box." update 4/20/20: "it took about 5 seconds to grab another head and open the box.".

• Brand Name: DELTA V-40 CERAMIC HEAD 36/0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10006521
• Report Number: 0002249697-2020-00820
• Device Sequence Number: 3817394
• Product Code: JDI
• UDI-Device Identifier: 04546540608512
• UDI-Public: 04546540608512
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 6570-0-136
• Device Catalogue Number: 6570-0-136
• Device Lot Number: 77871802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 08/25/2020
• 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: Other
• Patient Age: 49 YR
• Patient Weight: 91