MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL® LDH®, HEAD, 50, CODE P, TAPER 18/20; HIP PROSTHESIS

Model Number N/A

Device Problem Biocompatibility (2886)

Patient Problems Failure of Implant (1924); Necrosis (1971); Pain (1994); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530)

Event Date 06/09/2023

Event Type  Injury  

Event Description

It was reported that patient underwent revision of left hip resurfacing implant more than twenty years after initial surgery.Revision was performed due to pain, elevated metal ions & bladder dysfunction; ct scan revealed pseudotumor of left hip.During the surgery surgeon encountered black fluid, necrotic muscle, acetabulum bone deficiency and trunnionosis.Stem has been retained.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).G2: foreign - canada.D10: associated products: item reference: 01.00214.056, item name: metasulâ® duromâ®, component for acetabulum, uncemented, 56/㸠50, code p, item lot: 2380689.Item reference: unk, item name: zimmer biomet m/l stem, item lot: unk.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00361.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.D10: associated products: item reference: 01.00185.146, item name: metasulâ® ldhâ®, head adapter, m, 0, taper 12/14-18/20.Item lot:2390730 multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00603.The reported products were returned for investigation.In the as-received state, the head adapter was still fixed in the head taper: for further investigation, the parts were disassembled using the adapter extractor.On the articulating surface and on the flat rim of the cup numerous fine scratches are visible.The anchoring surface of the cup shows some bone ingrowth; the porous coating is overall intact with some polished areas.The articulating surface of the head exhibits some fine scratches and some electrocautery marks.The bevel of the head shows some scratches and dents.Signs of fretting corrosion can be seen on the head taper as well as on the inner and outer surface of the adapter.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.The patient is male and born in 1961.The patient underwent an initial left tha with metal-on-metal implants from zimmer biomet; as no medical documentation on this procedure is available, the exact date of the initial implantation could not be established.Later, the patient started to suffer of hip pain and bladder dysfunction.A first ct scan showed the presence of a pseudotumor originated in the hip joint.A second ct scan, taken on a later time point, showed an enlargement of the same pseudotumor.At the start of 2023, the patient underwent blood analysis, the results of which shows elevated metal ions level (chromium 23.1 nmol/l and cobalt 215.1 nmol/l).Subsequently, the patient underwent revision surgery during the summer of 2023.Surgical notes of the procedure report presence of black fluid in the hip joint.The cup and head were removed.The stem taper was found to have extensive trunniosis, but nevertheless was left implanted.Thorough irrigation and debridement were performed.Tunnelig and bone stock deficiency were noted in the anterior aspect of the acetabulum.Samples were taken and sent for bacteriological culture, the results of which showed no signs of infection.A total of (b)(4) intraoperative images taken during revision were provided.One of the image shows the surgical site during revision surgery: here it is possible to see that the neck and the taper of the stem are discolored, consistently with the trunniosis reported in the revision surgery notes.Nevertheless, due to the low quality of the image, a more in-depth analysis on the stem cannot be performed.The other intraoperative images provided were assessed but not here documented, as they do not provide any additional information for the reported event.Based on the analysis of the retrieval, it can be assumed that the reported event is due to the trunnionosis on the stem taper and the fretting corrosion on the adapter and on the taper of the head.Nevertheless, a definitive root cause for the deterioration of these contact surfaces cannot be established.Since the cause may be multifactorial, consisting of patient- and procedure-related factors, a definitive root cause could not be identified.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: METASUL® LDH®, HEAD, 50, CODE P, TAPER 18/20
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17246422
• MDR Text Key: 318285343
• Report Number: 0009613350-2023-00362
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024466487
• UDI-Public: (01)00889024466487(17)120331(10)2385673
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K053536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

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: Lay User/Patient
• Device Expiration Date: 03/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 01.00181.500
• Device Lot Number: 2385673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.; SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male